Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-02-20 @ 4:31 PM
Study NCT ID:
NCT01982968
Status:
COMPLETED
Last Update Posted:
2021-10-25
First Post:
2013-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of IPF With Laparoscopic Anti-Reflux Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D018662', 'term': 'Fundoplication'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Harold.Collard@ucsf.edu', 'phone': '415 4761000', 'title': 'Harold Collard, MD', 'organization': 'University of California, San Francisco'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '48 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'Subjects to receive standard anti-reflux treatment per clinical discretion', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'deathsNumAffected': 4, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Surgery', 'description': 'Subjects will receive laparoscopic fundoplication surgery\n\nSurgery: Full fundoplication surgery for the treatment of abnormal GER', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 9, 'seriousNumAtRisk': 29, 'deathsNumAffected': 1, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'gastrointestinal motility disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'incision site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Respiratory Worsening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'gastrointestinal haemorrhave', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'bile duct obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'cholecytitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Forced Vital Capacity (FVC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Subjects to receive standard anti-reflux treatment per clinical discretion'}, {'id': 'OG001', 'title': 'Surgery', 'description': 'Subjects will receive laparoscopic fundoplication surgery\n\nSurgery: Full fundoplication surgery for the treatment of abnormal Gastroesophageal reflux (GER)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.13', 'groupId': 'OG000', 'lowerLimit': '-.23', 'upperLimit': '-.02'}, {'value': '-0.05', 'groupId': 'OG001', 'lowerLimit': '-0.15', 'upperLimit': '0.05'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 48 weeks', 'description': 'Change in FVC (in liters) between enrollment and 48 weeks.', 'unitOfMeasure': 'liters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized patients'}, {'type': 'SECONDARY', 'title': 'Change in Score From Baseline for Acid and Non-acid Reflux Events at 48 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Subjects to receive standard anti-reflux treatment per clinical discretion'}, {'id': 'OG001', 'title': 'Surgery', 'description': 'Subjects will receive laparoscopic fundoplication surgery\n\nSurgery: Full fundoplication surgery for the treatment of abnormal Gastroesophageal reflux (GER)'}], 'classes': [{'title': 'Do you get heartburn?', 'categories': [{'measurements': [{'value': '-0.65', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '-1.04', 'spread': '0.95', 'groupId': 'OG001'}]}]}, {'title': 'Does your stomach get bloated?', 'categories': [{'measurements': [{'value': '-0.40', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '-0.39', 'spread': '0.99', 'groupId': 'OG001'}]}]}, {'title': 'Do you get bitter liquid (acid) in throat?', 'categories': [{'measurements': [{'value': '-0.63', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '-1.13', 'spread': '0.90', 'groupId': 'OG001'}]}]}, {'title': 'Do you burp a lot?', 'categories': [{'measurements': [{'value': '-0.25', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '1.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 48 weeks', 'description': 'Change in acid and non-acid reflux events from baseline to week 48. All subjects answered questions related to their reflux using a Likert scale (0 = never, 1 =occasionally, 2 = sometimes, 3 = often, 4 = always).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety of Laparoscopic Anti-reflux Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Subjects to receive standard anti-reflux treatment per clinical discretion'}, {'id': 'OG001', 'title': 'Surgery', 'description': 'Subjects will receive laparoscopic fundoplication surgery\n\nSurgery: Full fundoplication surgery for the treatment of abnormal Gastroesophageal reflux (GER)'}], 'classes': [{'title': 'All Cause Mortality', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Other (Not Including Serious) Adverse Events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 weeks', 'description': 'Overall safety of laparoscopic anti-reflux surgery in patients with IPF and abnormal GER as measured by number of participants who experienced death, serious adverse event, or other (not including serious) adverse event. See Adverse Events section for additional details.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'All-cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Subjects to receive standard anti-reflux treatment per clinical discretion'}, {'id': 'OG001', 'title': 'Surgery', 'description': 'Subjects will receive laparoscopic fundoplication surgery\n\nSurgery: Full fundoplication surgery for the treatment of abnormal Gastroesophageal reflux (GER)'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 weeks', 'description': 'Impact of anti-reflux surgery on all-cause mortality from enrollment to 48 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Non-elective Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Subjects to receive standard anti-reflux treatment per clinical discretion'}, {'id': 'OG001', 'title': 'Surgery', 'description': 'Subjects will receive laparoscopic fundoplication surgery\n\nSurgery: Full fundoplication surgery for the treatment of abnormal Gastroesophageal reflux (GER)'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and 48 weeks', 'description': 'Impact on non-elective hospitalizations from baseline to 48 weeks.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Acute Exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Subjects to receive standard anti-reflux treatment per clinical discretion'}, {'id': 'OG001', 'title': 'Surgery', 'description': 'Subjects will receive laparoscopic fundoplication surgery\n\nSurgery: Full fundoplication surgery for the treatment of abnormal Gastroesophageal reflux (GER)'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and 48 weeks', 'description': 'Impact on acute exacerbations of IPF from baseline to week 48.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'University of California San Diego (UCSD) Shortness of Breath Questionnaire (SOQB) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Subjects to receive standard anti-reflux treatment per clinical discretion'}, {'id': 'OG001', 'title': 'Surgery', 'description': 'Subjects will receive laparoscopic fundoplication surgery\n\nSurgery: Full fundoplication surgery for the treatment of abnormal Gastroesophageal reflux (GER)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.69', 'groupId': 'OG000', 'lowerLimit': '-6.24', 'upperLimit': '4.86'}, {'value': '0.71', 'groupId': 'OG001', 'lowerLimit': '-5.62', 'upperLimit': '4.21'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 48 weeks', 'description': 'Change in UCSD SOQB score from baseline to week 48. The score range is 0-120. Higher scores indicate higher breathlessness.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "St. George's Respiratory Questionnaire (SGRQ) Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Subjects to receive standard anti-reflux treatment per clinical discretion'}, {'id': 'OG001', 'title': 'Surgery', 'description': 'Subjects will receive laparoscopic fundoplication surgery\n\nSurgery: Full fundoplication surgery for the treatment of abnormal Gastroesophageal reflux (GER)'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.18', 'groupId': 'OG000', 'lowerLimit': '-8.35', 'upperLimit': '1.99'}, {'value': '1.04', 'groupId': 'OG001', 'lowerLimit': '-3.66', 'upperLimit': '5.74'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 48 weeks', 'description': 'Change in SGRQ score from baseline to week 48. The score range is 0-100. Higher scores indicate more limitations.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '6-minute Walk Distance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Subjects to receive standard anti-reflux treatment per clinical discretion'}, {'id': 'OG001', 'title': 'Surgery', 'description': 'Subjects will receive laparoscopic fundoplication surgery\n\nSurgery: Full fundoplication surgery for the treatment of abnormal Gastroesophageal reflux (GER)'}], 'classes': [{'categories': [{'measurements': [{'value': '9.13', 'groupId': 'OG000', 'lowerLimit': '-14.77', 'upperLimit': '33.02'}, {'value': '16.54', 'groupId': 'OG001', 'lowerLimit': '-4.80', 'upperLimit': '37.88'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 48 weeks', 'description': 'Change in 6-minute walk distance from baseline to week 48', 'unitOfMeasure': 'meters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cough Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Subjects to receive standard anti-reflux treatment per clinical discretion'}, {'id': 'OG001', 'title': 'Surgery', 'description': 'Subjects will receive laparoscopic fundoplication surgery\n\nSurgery: Full fundoplication surgery for the treatment of abnormal Gastroesophageal reflux (GER)'}], 'classes': [{'categories': [{'measurements': [{'value': '7.15', 'groupId': 'OG000', 'lowerLimit': '-2.01', 'upperLimit': '16.31'}, {'value': '4.74', 'groupId': 'OG001', 'lowerLimit': '-3.14', 'upperLimit': '12.63'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 48 weeks', 'description': 'Change in VAS from baseline to week 48. The scale range is 1-100. Lower scores indicate no cough and 100 indicates the worst cough.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'High-Resolution CT (HRCT) Fibrosis Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Subjects to receive standard anti-reflux treatment per clinical discretion'}, {'id': 'OG001', 'title': 'Surgery', 'description': 'Subjects will receive laparoscopic fundoplication surgery\n\nSurgery: Full fundoplication surgery for the treatment of abnormal Gastroesophageal reflux (GER)'}], 'timeFrame': 'Baseline to 48 weeks', 'description': 'Change in HRCT fibrosis score from baseline to week 48. HRCT Fibrosis score is calculated as a percentage. Higher percentage indicates more fibrosis.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are not available to be reported due to inability to obtain imaging data on participants and generate a score.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'Subjects to receive standard anti-reflux treatment per clinical discretion'}, {'id': 'FG001', 'title': 'Surgery', 'description': 'Subjects will receive laparoscopic fundoplication surgery\n\nSurgery: Full fundoplication surgery for the treatment of abnormal GER'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'Subjects to receive standard anti-reflux treatment per clinical discretion'}, {'id': 'BG001', 'title': 'Surgery', 'description': 'Subjects will receive laparoscopic fundoplication surgery\n\nSurgery: Full fundoplication surgery for the treatment of abnormal GER'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.2', 'spread': '7.35', 'groupId': 'BG000'}, {'value': '70.6', 'spread': '5.97', 'groupId': 'BG001'}, {'value': '69.9', 'spread': '6.67', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-04-08', 'size': 571878, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-09-02T19:21', 'hasProtocol': True}, {'date': '2016-07-19', 'size': 292510, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-09-02T19:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-27', 'studyFirstSubmitDate': '2013-11-06', 'resultsFirstSubmitDate': '2018-12-07', 'studyFirstSubmitQcDate': '2013-11-06', 'lastUpdatePostDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-27', 'studyFirstPostDateStruct': {'date': '2013-11-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forced Vital Capacity (FVC)', 'timeFrame': 'Baseline and 48 weeks', 'description': 'Change in FVC (in liters) between enrollment and 48 weeks.'}], 'secondaryOutcomes': [{'measure': 'Change in Score From Baseline for Acid and Non-acid Reflux Events at 48 Weeks', 'timeFrame': 'Baseline and 48 weeks', 'description': 'Change in acid and non-acid reflux events from baseline to week 48. All subjects answered questions related to their reflux using a Likert scale (0 = never, 1 =occasionally, 2 = sometimes, 3 = often, 4 = always).'}, {'measure': 'Safety of Laparoscopic Anti-reflux Surgery', 'timeFrame': '48 weeks', 'description': 'Overall safety of laparoscopic anti-reflux surgery in patients with IPF and abnormal GER as measured by number of participants who experienced death, serious adverse event, or other (not including serious) adverse event. See Adverse Events section for additional details.'}, {'measure': 'All-cause Mortality', 'timeFrame': '48 weeks', 'description': 'Impact of anti-reflux surgery on all-cause mortality from enrollment to 48 weeks'}, {'measure': 'Non-elective Hospitalization', 'timeFrame': 'Baseline and 48 weeks', 'description': 'Impact on non-elective hospitalizations from baseline to 48 weeks.'}, {'measure': 'Acute Exacerbations', 'timeFrame': 'Baseline and 48 weeks', 'description': 'Impact on acute exacerbations of IPF from baseline to week 48.'}, {'measure': 'University of California San Diego (UCSD) Shortness of Breath Questionnaire (SOQB) Score', 'timeFrame': 'Baseline and 48 weeks', 'description': 'Change in UCSD SOQB score from baseline to week 48. The score range is 0-120. Higher scores indicate higher breathlessness.'}, {'measure': "St. George's Respiratory Questionnaire (SGRQ) Score", 'timeFrame': 'Baseline and 48 weeks', 'description': 'Change in SGRQ score from baseline to week 48. The score range is 0-100. Higher scores indicate more limitations.'}, {'measure': '6-minute Walk Distance', 'timeFrame': 'Baseline and 48 weeks', 'description': 'Change in 6-minute walk distance from baseline to week 48'}, {'measure': 'Cough Visual Analog Scale (VAS)', 'timeFrame': 'Baseline and 48 weeks', 'description': 'Change in VAS from baseline to week 48. The scale range is 1-100. Lower scores indicate no cough and 100 indicates the worst cough.'}, {'measure': 'High-Resolution CT (HRCT) Fibrosis Score.', 'timeFrame': 'Baseline to 48 weeks', 'description': 'Change in HRCT fibrosis score from baseline to week 48. HRCT Fibrosis score is calculated as a percentage. Higher percentage indicates more fibrosis.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Idiopathic pulmonary fibrosis', 'IPF', 'Gastroesophageal reflux', 'GER', 'GERD'], 'conditions': ['Idiopathic Pulmonary Fibrosis', 'Gastroesophageal Reflux']}, 'referencesModule': {'references': [{'pmid': '30100404', 'type': 'RESULT', 'citation': 'Raghu G, Pellegrini CA, Yow E, Flaherty KR, Meyer K, Noth I, Scholand MB, Cello J, Ho LA, Pipavath S, Lee JS, Lin J, Maloney J, Martinez FJ, Morrow E, Patti MG, Rogers S, Wolters PJ, Yates R, Anstrom KJ, Collard HR. Laparoscopic anti-reflux surgery for the treatment of idiopathic pulmonary fibrosis (WRAP-IPF): a multicentre, randomised, controlled phase 2 trial. Lancet Respir Med. 2018 Sep;6(9):707-714. doi: 10.1016/S2213-2600(18)30301-1. Epub 2018 Aug 9.'}]}, 'descriptionModule': {'briefSummary': 'This study will test the hypothesis that treatment with laparoscopic anti-reflux surgery in subjects with idiopathic pulmonary fibrosis (IPF) and abnormal gastroesophageal reflux (GER) will slow the decline of forced vital capacity (FVC) over 48 weeks.', 'detailedDescription': 'This protocol proposes to test the following hypothesis: Treatment with laparoscopic anti-reflux surgery in subjects with idiopathic pulmonary fibrosis (IPF) and abnormal gastroesophageal (GER) reflux will slow the decline of forced vital capacity (FVC) over 48 weeks. This study will randomize approximately 58 subjects with IPF and abnormal acid reflux on 24-hour impedance / pH monitoring to laparoscopic anti-reflux surgery or standard care (randomization ratio 1:1). Subjects will be followed for 48 weeks or until the time of lung transplantation or death.\n\nWe aim to achieve the following: determine the impact of laparoscopic anti-reflux surgery on change in FVC over 48 weeks in patients with IPF and abnormal GER; correlate the reduction in acid and non-acid reflux events with the change in FVC over 48 weeks in patients with IPF and abnormal GER; determine the safety of laparoscopic anti-reflux surgery in patients with IPF and abnormal GER; explore the impact of laparoscopic anti-reflux surgery on key secondary endpoints over 48 weeks in patients with IPF and abnormal GER; identify molecular markers of IPF disease activity and gastroesophageal reflux in biological samples from patients with IPF and abnormal GER.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of idiopathic pulmonary fibrosis\n* Abnormal GER on 24-hour pH monitoring (DeMeester score \\> 14.7)\n* Able to provide informed consent\n* Willing to undergo laparoscopic anti-reflux surgery\n\nExclusion Criteria:\n\n* FVC \\< 50% predicted\n* FEV1/FVC ratio \\< 0.65\n* Resting room air PaO2 \\< 60mm Hg\n* Unable to walk 50 meters on 6 minute walk test\n* Acute respiratory illness in last 12 weeks\n* Experimental medication for IPF in last 28 days\n* Listed for lung transplantation at screening\n* Unable to safely undergo surgery\n* History of esophageal / bariatric / gastric surgery\n* History of cancer (other than non-melanoma skin cancer) in last 3 years\n* Pregnant at time of screening or enrollment\n* Unable to obtain pre-authorized approval from a third party payer for surgery and related costs\n* Life expectancy \\< 48 weeks due to another illness\n* BMI \\> 35\n* Known severe pulmonary hypertension (mean pressure \\> 35 mm Jg on RHC; RVSP \\> 50 mm Hg on ECHO)'}, 'identificationModule': {'nctId': 'NCT01982968', 'acronym': 'WRAP-IPF', 'briefTitle': 'Treatment of IPF With Laparoscopic Anti-Reflux Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Weighing Risks and Benefits of Laparoscopic Anti-Reflux Surgery in Patients With Idiopathic Pulmonary Fibrosis', 'orgStudyIdInfo': {'id': 'Pro00049804'}, 'secondaryIdInfos': [{'id': '1UM1HL119089', 'link': 'https://reporter.nih.gov/quickSearch/1UM1HL119089', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Subjects to receive standard anti-reflux treatment per clinical discretion'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Surgery', 'description': 'Subjects will receive laparoscopic fundoplication surgery', 'interventionNames': ['Procedure: Surgery']}], 'interventions': [{'name': 'Surgery', 'type': 'PROCEDURE', 'otherNames': ['Nissen fundoplication', 'Laparoscopic fundoplication', 'Laparoscopic anti-reflux surgery'], 'description': 'Full fundoplication surgery for the treatment of abnormal GER', 'armGroupLabels': ['Surgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Harold R Collard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Ganesh Raghu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}, {'name': 'Kevin J Anstrom, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}