Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2026-01-05 @ 1:32 AM
Study NCT ID:
NCT00622804
Status:
WITHDRAWN
Last Update Posted:
2009-08-03
First Post:
2008-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Study for Bile Reflux and Gastric Stasis in Patients After Distal Gastrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D011178', 'term': 'Postgastrectomy Syndromes'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005763', 'term': 'Gastroenterostomy'}, {'id': 'D015390', 'term': 'Gastric Bypass'}], 'ancestors': [{'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D050110', 'term': 'Bariatric Surgery'}, {'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'whyStopped': 'It was very difficult to enroll patients in this study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'lastUpdateSubmitDate': '2009-07-31', 'studyFirstSubmitDate': '2008-02-14', 'studyFirstSubmitQcDate': '2008-02-22', 'lastUpdatePostDateStruct': {'date': '2009-08-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bile reflux by Dual scintigraphy', 'timeFrame': 'six month and one year after operation'}], 'secondaryOutcomes': [{'measure': 'Gastric emptying time by Dual scintigraphy', 'timeFrame': 'six month and one year after operation'}, {'measure': 'Residual food, gastritis, bile reflux and reflux esophagitis by Gastrofiberscope findings', 'timeFrame': 'six month and one year after operation'}, {'measure': 'Quality of life by EORTC QLQ30, STO22', 'timeFrame': 'one year after operation'}, {'measure': 'Morbidity and Mortality', 'timeFrame': 'In hosipital'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stomach cancer', 'Gastrectomy', 'Postgastrectomy syndrome'], 'conditions': ['Stomach Cancer', 'Gastrectomy']}, 'referencesModule': {'references': [{'pmid': '16024924', 'type': 'BACKGROUND', 'citation': 'Ogoshi K, Okamoto Y, Nabeshima K, Morita M, Nakamura K, Iwata K, Soeda J, Kondoh Y, Makuuchi H. Focus on the conditions of resection and reconstruction in gastric cancer. What extent of resection and what kind of reconstruction provide the best outcomes for gastric cancer patients? Digestion. 2005;71(4):213-24. doi: 10.1159/000087046. Epub 2004 Sep 6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the degree of bile reflux and gastric stasis according the reconstruction methods after distal subtotal gastrectomy for gastric cancer, and to find out the proper method. We collect ninety patients who undergo distal gastrectomy for gastric cancers for this study from 5 institutions and randomly divide into 3 groups according to reconstruction methods: 1) Billroth-II (B-II), 2) Roux en Y gastrojejunostomy (RY-GJ) and 3) uncut Roux en Y gastrojejunostomy (uncut RY-GJ).', 'detailedDescription': 'Patients who have undergone gastrectomy for gastric cancer might be developed various symptoms by gastric stasis and bile reflux, it so called "post-gastrectomy syndrome", because of the diminishment of stomach capacity, the decrease of expulsive ability and the change of food passage. Until now, that had been accepted as the inevitable results after gastric resection. However, the survival rate has recently been increased owing to the increased proportion of early gastric cancer. And thus, to improve the quality of life of patients, many researchers have been actually studying for the reconstruction methods which are able to minimize the symptom by gastrectomy, but it is dissatisfied until now. Thus, the purpose of this study is to evaluate the degree of bile reflux and gastric stasis according the reconstruction methods after distal subtotal gastrectomy for gastric cancer, and to find out the proper method.\n\nWe collect ninety patients who undergo distal gastrectomy for gastric cancers for this study from 5 institutions and randomly divide into 3 groups according to reconstruction methods: 1) Billroth-II (B-II), 2) Roux en Y gastrojejunostomy (RY-GJ) and 3) uncut Roux en Y gastrojejunostomy (uncut RY-GJ). We evaluate the postoperative morbidity rate and then the degree of bile reflux, gastric emptying time and quality of life through long term follow-up using the gastrofiberscope, survey and so on.\n\nFrom this study, we would suggest the standard reconstruction procedure after distal gastrectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent distal gastrectomy for adenocarcinoma of stomach with following criteria:\n\n 1. have cancer located in middle or distal portions\n 2. preoperative staged as cT1N0M0 or cT2N0M0 by computed tomography and gastrofiberscope (Endoscopic ultrasound, optionally)\n 3. have The American Society of Anaesthesiologists (ASA) score of three and less\n\nExclusion Criteria:\n\n* Patients following criteria:\n\n 1. have simultaneously other cancer\n 2. underwent cancer therapy (radiologic or immunologic or chemotherapeutic method) at past time\n 3. have systemic inflammatory disease\n 4. have upper gastrointestinal surgery\n 5. have the gastric cancer with obstruction\n 6. get pregnancy\n 7. are treating diabetics with Insulin\n 8. are participating or participated within 1 month in other clinical trials\n 9. have BMI less than 25\n 10. are expected to perform laparoscopy assisted gastrectomy'}, 'identificationModule': {'nctId': 'NCT00622804', 'briefTitle': 'Comparison Study for Bile Reflux and Gastric Stasis in Patients After Distal Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'The Catholic University of Korea'}, 'officialTitle': 'Phase III Study on Comparison for Bile Reflux and Gastric Stasis in Patients With Gastric Cancer After Distal Gastrectomy', 'orgStudyIdInfo': {'id': 'HCHC06OT049'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'Billroth-II (B-II)reconstruction', 'interventionNames': ['Procedure: Billroth-II (B-II)']}, {'type': 'OTHER', 'label': '2', 'description': 'Roux en Y gastrojejunostomy (RY-GJ)', 'interventionNames': ['Procedure: Roux en Y gastrojejunostomy (RY-GJ)']}, {'type': 'OTHER', 'label': '3', 'description': 'uncut Roux en Y gastrojejunostomy (uncut RY-GJ)', 'interventionNames': ['Procedure: uncut Roux en Y gastrojejunostomy']}], 'interventions': [{'name': 'Billroth-II (B-II)', 'type': 'PROCEDURE', 'otherNames': ['B-II'], 'description': 'After conventional distal gastrectomy with lymphadenectomy, jejunum of a distal segment from 10 to 20cm from Treitz is used for reconstruction. Jejunal segment is transposed in a way of ante-colon, and then gastrojejunostomy is performed using 60mm linear cutting stapler or hand-sawing technique with absorbable suture. After anastomosis, reinforcement suture is done.', 'armGroupLabels': ['1']}, {'name': 'Roux en Y gastrojejunostomy (RY-GJ)', 'type': 'PROCEDURE', 'otherNames': ['RY-GJ'], 'description': 'After conventional distal gastrectomy with lymphadenectomy, jejunum is transected in the segment from 10 to 20 cm, and then distal end is transposed in a way of retro-colon to perform anastomosis using 60mm linear cutting stapler or hand-sawing technique with absorbable suture. After anastomosis, reinforcement suture is done. The resected proximal jejunum and the portion of jejunum distal 45 cm from gastrojejunostomy are anastomosed using 60mm linear cutting stapler or hand-sawing technique with absorbable suture followed by reinforcement suture.', 'armGroupLabels': ['2']}, {'name': 'uncut Roux en Y gastrojejunostomy', 'type': 'PROCEDURE', 'otherNames': ['uncut RY-GJ'], 'description': 'After conventional distal gastrectomy with lymphadenectomy, jejunum of distal segment 45 cm from Treitz ligament is used for reconstruction. Jejunal segment is transposed in a way of ante-colon, and then gastrojejunostomy is performed using 60mm linear cutting stapler or hand-sawing technique with absorbable suture followed by reinforcement suture. After anastomosis, afferent loop distal 5cm is obstructed using non-cutting stapler or hand sawing suture. And then, distal jejunum 10 cm from obstructive portion and efferent jejunal loop distal 45 cm from gastrojejunostomy are anastomosed in a manner of side to side followed by reinforcement suture.', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '420-717', 'city': 'Bucheon-si', 'country': 'South Korea', 'facility': 'Department of Surgery, Holy Family Hospital, The Catholic University of Korea', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'zip': '403-720', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Department of Surgery, Our Lady of Mercy Hospital, The Catholic University of Korea', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '137-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Department of Surgery, Kangnam St. Mary's Hospital, The Catholic University of Korea", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '150-713', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Department of Surgery, St Mary's Hospital, The Catholic University of Korea", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '442-723', 'city': 'Suwon', 'country': 'South Korea', 'facility': "Department of Surgery, St. Vincent's Hopital, The Catholic University of Korea", 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'overallOfficials': [{'name': 'Wook Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Surgery, Holy Family Hospital, The Catholic University of Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Catholic University of Korea', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Wook Kim', 'oldOrganization': 'Department of Surgery, Holy Family Hospital, College of Medicine'}}}}