Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-01-21 @ 7:30 PM
Study NCT ID:
NCT02999451
Status:
COMPLETED
Last Update Posted:
2020-06-30
First Post:
2016-11-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Snare-assisted POEM for Treatment of 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': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-26', 'studyFirstSubmitDate': '2016-11-29', 'studyFirstSubmitQcDate': '2016-12-20', 'lastUpdatePostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical success rates', 'timeFrame': '12 months after treatment', 'description': 'Clinical success is defined as a post-POEM Eckardt score ≤3 without additional treatment (Eckardt AJ et al, Nat Rev Gastroenterol Hepatol 2011).'}], 'secondaryOutcomes': [{'measure': 'Procedure-related adverse events', 'timeFrame': 'baseline to 12 months after treatment', 'description': 'Adverse events are defined and graded according to the American Society for Gastrointestinal Endoscopy lexicon (Cotton PB et al, Gastrointest Endosc 2010). Incidental findings of pneumoperitoneum, pneumothorax, pneumomediastinum, pleural effusion on postoperative imaging, and subcutaneous emphysema were documented while not considered as adverse events.'}, {'measure': 'Procedure time', 'timeFrame': 'POEM procedure', 'description': 'Procedure time is measured from the start of submucosal injection until mucosal entry closure.'}, {'measure': 'The volume of intraoperative bleeding', 'timeFrame': 'POEM procedure'}, {'measure': 'The use of hemostatic forceps', 'timeFrame': 'POEM procedure'}, {'measure': 'Postoperative pain requiring the use of tramadol', 'timeFrame': 'Through hospital stay after procedure, an average of 2-7 days', 'description': 'Pain related to POEM procedure requiring the use of tramadol pain medication.'}, {'measure': 'The length of postoperative hospital stay', 'timeFrame': 'Through hospital stay after procedure, an average of 2-7 daysc'}, {'measure': 'Total hospital costs of treatment per participants', 'timeFrame': 'Through hospital stay after procedure, an average of 2-7 days'}, {'measure': 'Eckardt score', 'timeFrame': 'baseline, 3 months and 12 months after treatment', 'description': 'The Eckardt score assesses the severity of achalasia symptoms by combining the sum of symptom frequency scores for dysphagia, regurgitation, and chest pain and a weight loss score. Each component can be graded from 0 to 3 points. The total range is 0 to 12, with higher scores indicating more severe symptoms (Eckardt AJ et al, Nat Rev Gastroenterol Hepatol 2011).'}, {'measure': 'Manometry parameters', 'timeFrame': 'baseline and 3 months after treatment', 'description': 'Manometry parameters include lower esophageal sphincter (LES) pressure and integrated relaxation pressure (IRP) on high resolution manometry.'}, {'measure': 'Maximum esophageal diameter on barium esophagram', 'timeFrame': 'baseline and 3 months after treatment'}, {'measure': 'Gastroesophageal reflux disease questionnaire (GerdQ) score', 'timeFrame': 'baseline, 3 months and 12 months after treatment', 'description': 'The GerdQ has been developed as a tool to facilitate the symptom-based diagnosis of GERD. Scores ranging from 0 to 3 were applied for the four positive predictors (heartburn, regurgitation, sleep disturbance due to reflux symptoms and use of over-the-counter medications for reflux symptoms) and from 3 to 0 for two negative predictors (epigastric pain and nausea). The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18. A total GerdQ score \\>7 is considered indicative of significant GERD symptoms (Jones R et al, Aliment Pharmacol Ther 2009).'}, {'measure': 'Reflux esophagitis on post-POEM endoscopy', 'timeFrame': '3 months after treatment', 'description': 'The severity of reflux esophagitis is graded according to the Los Angeles classification (Armstrong D et al, Gastroenterology 1996).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peroral endoscopic myotomy', 'Snare', 'Endoscopic knife', 'Esophageal Achalasia'], 'conditions': ['Esophageal Achalasia']}, 'descriptionModule': {'briefSummary': 'POEM is a new intervention for the treatment of achalasia and has been reported to relieve the dysphagia symptom effectively. Although the cost of POEM method is less than the method of Laparoscopic Heller Myotomy and Fundoplication, it is still of an economic burden for the patients with achalasia. In this trial, investigators plan to use snare to assist POEM procedure, to observe the safety, efficacy and cost-effectiveness of this method, compared with other knifes-assisted procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18-70 years\n* Diagnosed as achalasia base on high resolution manometry, barium esophagram and Upper endoscopy\n* Signed written informed consent\n\nExclusion Criteria:\n\n* ASA class \\> Ⅲ\n* Previous endoscopic or surgical treatment for achalasia\n* Esophageal malignancy\n* Pregnant'}, 'identificationModule': {'nctId': 'NCT02999451', 'briefTitle': 'Snare-assisted POEM for Treatment of Esophageal Achalasia', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'Safety, Efficacy and Cost-effectiveness of Snare-assisted POEM for Treatment of Esophageal Achalasia', 'orgStudyIdInfo': {'id': '123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'snare group', 'description': 'snare-assisted POEM', 'interventionNames': ['Device: snare-assisted POEM']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional group', 'description': 'knife-assisted POEM', 'interventionNames': ['Device: knife-assisted POEM']}], 'interventions': [{'name': 'snare-assisted POEM', 'type': 'DEVICE', 'description': 'POEM is performed by using a snare which is retracted into the sheath to expose the tip, leaving a 1-2mm length for operation.\n\n1. After submucosal injection, an initial 2-cm mucosal incision is made by a snare in the posterior esophageal wall.\n2. A submucosal tunnel from the esophagus to the gastric cardia is created using a snare.\n3. Full-thickness myotomy is performed and extended 2-3 cm beyond the esophagogastric junction (EGJ) using a snare.\n4. The mucosal incision is closed with endoclips.', 'armGroupLabels': ['snare group']}, {'name': 'knife-assisted POEM', 'type': 'DEVICE', 'description': 'POEM is performed by using a conventional endoscopic knife.\n\n1. After submucosal injection, an initial 2-cm mucosal incision is made by a knife in the posterior esophageal wall.\n2. A submucosal tunnel from the esophagus to the gastric cardia is created using a knife.\n3. Full-thickness myotomy is performed and extended 2-3 cm beyond the esophagogastric junction (EGJ) using a knife.\n4. The mucosal incision is closed with endoclips.', 'armGroupLabels': ['conventional group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'First Affiliated Hospital of Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Xiangbin Xing, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Xiangbin Xing', 'investigatorAffiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}}}}