Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT01742494
Status:
UNKNOWN
Last Update Posted:
2012-12-05
First Post:
2012-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Study of Conventional POEM and Hybrid POEM for Esophageal Achalasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004931', 'term': 'Esophageal Achalasia'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-12-02', 'studyFirstSubmitDate': '2012-11-20', 'studyFirstSubmitQcDate': '2012-12-02', 'lastUpdatePostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Therapeutic success', 'timeFrame': 'Every 3 months after innitial intervention via telephone questionnaires during follow-up up to 1 year', 'description': 'a reduction in the Eckardt score to ≤3'}], 'primaryOutcomes': [{'measure': 'Procedure time in both groups', 'timeFrame': 'during POEM procedure'}], 'secondaryOutcomes': [{'measure': 'clinical efficacy and safety', 'timeFrame': 'during hospital stay and up to 1 year', 'description': 'bleeding complications, pneumothorax or pleural effusion requiring intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Esophageal Achalasia,', 'Peroral endoscopic myotomy,', 'Water-jet assisted'], 'conditions': ['Esophageal Achalasia']}, 'referencesModule': {'references': [{'pmid': '24232052', 'type': 'DERIVED', 'citation': 'Cai MY, Zhou PH, Yao LQ, Xu MD, Zhong YS, Li QL, Chen WF, Hu JW, Cui Z, Zhu BQ. Peroral endoscopic myotomy for idiopathic achalasia: randomized comparison of water-jet assisted versus conventional dissection technique. Surg Endosc. 2014 Apr;28(4):1158-65. doi: 10.1007/s00464-013-3300-1.'}]}, 'descriptionModule': {'briefSummary': 'Peroral endoscopic myotomy (POEM) has recently been introduced as promising alternative to laparoscopic Heller myotomy for patients with idiopathic achalasia. Several technical modifications have been proposed but have not yet been tested in randomized trials.', 'detailedDescription': 'Objective: To evaluate efficacy and safety of water-jet assisted POEM (WJ) versus the conventional technique (C).\n\nInterventions: Patients with achalasia diagnosed by symptoms, endoscopy and barium swallow eligible for POEM were randomized to either the use of Erbe Hybrid knife (WJ group) or the conventional technique using injection and triangle tip knife interchangeably (C group).\n\nMain outcome measurements: Procedure time in both groups; secondary outcomes were clinical efficacy and safety (bleeding complications, pneumothorax or pleural effusion requiring intervention)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* With an Eckardt symptom score ≥ 4\n* The diagnosis of achalasia was made on the basis of the absence of peristalsis and on impaired relaxation of the LES on established methods (barium swallow, manometry, esophagogastroduodenoscopy)\n* Informed patient consent was obtained\n\nExclusion Criteria:\n\n* Severe cardiopulmonary disease or other serious disease leading to unacceptable surgical risk\n* Pseudoachalasia\n* Megaesophagus (diameter of \\> 7 cm)'}, 'identificationModule': {'nctId': 'NCT01742494', 'briefTitle': 'Comparison Study of Conventional POEM and Hybrid POEM for Esophageal Achalasia', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Peroral Endoscopic Myotomy for Esophageal Achalasia: Randomized Comparison of Water-Jet Assisted Versus Conventional Dissection Technique', 'orgStudyIdInfo': {'id': 'Hybrid POEM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Water-jet POEM', 'description': 'POEM were performed by the use of Erbe Hybrid knife (WJ group)', 'interventionNames': ['Procedure: Water-jet POEM']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional POEM', 'description': 'POEM were performed by the conventional technique using injection and triangle tip knife (C group).', 'interventionNames': ['Procedure: Conventional POEM']}], 'interventions': [{'name': 'Water-jet POEM', 'type': 'PROCEDURE', 'description': 'Water-jet assisted POEM procedure was performed', 'armGroupLabels': ['Water-jet POEM']}, {'name': 'Conventional POEM', 'type': 'PROCEDURE', 'description': 'POEM were performed by the use of conventional technique using injection and triangle tip knife.', 'armGroupLabels': ['Conventional POEM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ping-Hong Zhou, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Ping-Hong Zhou, M.D, PhD', 'role': 'CONTACT', 'email': 'zhou1968@yahoo.cn', 'phone': '86-13681971063'}], 'overallOfficials': [{'name': 'Ping-Hong Zhou, M.D., PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}