Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-30 @ 11:48 AM
Study NCT ID:
NCT04578769
Status:
RECRUITING
Last Update Posted:
2025-12-10
First Post:
2020-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Different Modified POEM for 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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2020-09-26', 'studyFirstSubmitQcDate': '2020-10-01', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Therapeutic success of short term', 'timeFrame': '6 months after the procedure', 'description': 'Clinical severity was assessed using the Eckardt score. This score is the sum of the symptom scores for dysphagia, regurgitation, and chest pain (with 0 indicating the absence of symptoms, 1 indicating occasional symptoms, 2 indicating daily symptoms, and 3 indicating symptoms at each meal) and weight loss (with 0 indicating no weight loss, 1 indicating a loss of \\<5 kg, 2 indicating a loss of 5 to 10 kg, and 3 indicating a loss of \\>10 kg). The total score ranges from 0 to 12, with higher scores indicating more severe disease symptomatology. (Eckardt, V. Gastroenterology, 1992. 103(6): 1732-8.'}], 'secondaryOutcomes': [{'measure': 'Procedure time', 'timeFrame': 'During the endoscopic procedure', 'description': 'The duration of the endoscopic procedures for each patients will be calculated, in minutes, since the mucosal incision until the endoscopic closure of the mucosal entry with the last endoscopic clip.'}, {'measure': 'Pressure changes by high-resolution manometry (HRM)', 'timeFrame': '6 month after the procedure', 'description': 'Basal lower esophageal sphincter (LES) pressure, Distal contractile integral (DCI) and integrated relaxation pressure (IRP)'}, {'measure': 'barium esophagogram', 'timeFrame': '6 month after the procedure', 'description': 'Barium swallow studies will be done to evaluate the oesophageal emptying at 5 minutes and esophageal distortion'}, {'measure': 'Rate of intra-procedure complications', 'timeFrame': 'During the endoscopic procedure', 'description': 'Complications encountered during the procedure will be noted. (perforation, delayed bleeding, pneumothorax, subcutaneous emphysema, anastomotic leak etc.)'}, {'measure': 'the rate and severity of oesophagitis', 'timeFrame': '6 months after the procedure', 'description': 'oesphagitis was identified under esophagogastroduodenoscopy, and was classified according to the Los Angeles Classification'}, {'measure': '(4) Esophagogastroduodenoscopy (EGD) with the novel Endoscopic Scoring for Achalasia (CARS)', 'timeFrame': '6-month after the procedure', 'description': 'Endoscopic evaluation was performed using the Contents, Anatomy, Resistance, and Stasis (CARS) score. This scoring system was developed and validated through video-based reliability assessments and initially demonstrated strong clinical utility for predicting achalasia. The score assigns 0 to 2 points each for Contents, Anatomy, and Resistance at the lower esophageal sphincter, and 1 point for each component of Stasis. The total score ranges from 0 to 8, with higher scores indicating a worse endoscopic outcome.'}, {'measure': 'POEM difficulty evaluation', 'timeFrame': 'During the endoscopic procedure', 'description': '① Peroral Endoscopic Myotomy (POEM) difficulty score (PDS). The score consists of five variables: Fibrosis, Oozing, Orientation, Distension of tunnel, and Spastic contractions ("FOODS"). Each variable was arbitrarily weighted equally and assigned values ranging from 0 to 2. The PDS was completed immediately post-procedure in the operating room. The total score ranges from 0 to 10, with higher scores indicating greater technical difficulty. ② bleeding episodes, classified into (1) none to minimal (2) moderate to diffuse'}, {'measure': 'perioperative hospitalization', 'timeFrame': 'perioperative period', 'description': 'perioperative hospitalization length'}, {'measure': 'post-POEM persistent pain', 'timeFrame': 'postoperative period', 'description': 'Post-POEM persistent pain was defined as pain requiring level 2 or 3 analgesics.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['peroral endoscopic myotomy', 'Achalasia', 'thickness of myotomy'], 'conditions': ['Esophageal Achalasia']}, 'referencesModule': {'references': [{'pmid': '25469569', 'type': 'BACKGROUND', 'citation': 'Kahrilas PJ, Bredenoord AJ, Fox M, Gyawali CP, Roman S, Smout AJ, Pandolfino JE; International High Resolution Manometry Working Group. The Chicago Classification of esophageal motility disorders, v3.0. Neurogastroenterol Motil. 2015 Feb;27(2):160-74. doi: 10.1111/nmo.12477. Epub 2014 Dec 3.'}, {'pmid': '31559513', 'type': 'BACKGROUND', 'citation': 'Inoue H, Shiwaku H, Kobayashi Y, Chiu PWY, Hawes RH, Neuhaus H, Costamagna G, Stavropoulos SN, Fukami N, Seewald S, Onimaru M, Minami H, Tanaka S, Shimamura Y, Santi EG, Grimes K, Tajiri H. Statement for gastroesophageal reflux disease after peroral endoscopic myotomy from an international multicenter experience. Esophagus. 2020 Jan;17(1):3-10. doi: 10.1007/s10388-019-00689-6. Epub 2019 Sep 26.'}, {'pmid': '30022514', 'type': 'BACKGROUND', 'citation': 'Inoue H, Shiwaku H, Iwakiri K, Onimaru M, Kobayashi Y, Minami H, Sato H, Kitano S, Iwakiri R, Omura N, Murakami K, Fukami N, Fujimoto K, Tajiri H. Clinical practice guidelines for peroral endoscopic myotomy. Dig Endosc. 2018 Sep;30(5):563-579. doi: 10.1111/den.13239.'}, {'pmid': '25214469', 'type': 'BACKGROUND', 'citation': 'Wang J, Tan N, Xiao Y, Chen J, Chen B, Ma Z, Zhang D, Chen M, Cui Y. Safety and efficacy of the modified peroral endoscopic myotomy with shorter myotomy for achalasia patients: a prospective study. Dis Esophagus. 2015 Nov-Dec;28(8):720-7. doi: 10.1111/dote.12280. Epub 2014 Sep 12.'}, {'pmid': '30187204', 'type': 'BACKGROUND', 'citation': 'Li L, Chai N, Linghu E, Li Z, Du C, Zhang W, Zou J, Xiong Y, Zhang X, Tang P. Safety and efficacy of using a short tunnel versus a standard tunnel for peroral endoscopic myotomy for Ling type IIc and III achalasia: a retrospective study. Surg Endosc. 2019 May;33(5):1394-1402. doi: 10.1007/s00464-018-6414-7. Epub 2018 Sep 5.'}, {'pmid': '30054739', 'type': 'BACKGROUND', 'citation': 'Kane ED, Budhraja V, Desilets DJ, Romanelli JR. Myotomy length informed by high-resolution esophageal manometry (HREM) results in improved per-oral endoscopic myotomy (POEM) outcomes for type III achalasia. Surg Endosc. 2019 Mar;33(3):886-894. doi: 10.1007/s00464-018-6356-0. Epub 2018 Jul 27.'}, {'pmid': '27895430', 'type': 'BACKGROUND', 'citation': 'Wang XH, Tan YY, Zhu HY, Li CJ, Liu DL. Full-thickness myotomy is associated with higher rate of postoperative gastroesophageal reflux disease. World J Gastroenterol. 2016 Nov 14;22(42):9419-9426. doi: 10.3748/wjg.v22.i42.9419.'}, {'pmid': '23891074', 'type': 'BACKGROUND', 'citation': 'Li QL, Chen WF, Zhou PH, Yao LQ, Xu MD, Hu JW, Cai MY, Zhang YQ, Qin WZ, Ren Z. Peroral endoscopic myotomy for the treatment of achalasia: a clinical comparative study of endoscopic full-thickness and circular muscle myotomy. J Am Coll Surg. 2013 Sep;217(3):442-51. doi: 10.1016/j.jamcollsurg.2013.04.033. Epub 2013 Jul 25.'}]}, 'descriptionModule': {'briefSummary': 'The aims of this study is to compare the efficacy and safety of conventional myotomy (circular myotomy) and modified myotomy (full-thickness myotomy) in the treatment of achalasia patients.', 'detailedDescription': "Peroral endoscopic myotomy (POEM) is a novel clinical technique used to treat achalasia. The conventional POEM myotomy length averages 8 to 10 cm (4-6 cm in the esophagus, 2-4cm in the LES, 2cm in the cardia \\& 6-8 cm above and 2 cm below the gastroesophageal junction \\[GEJ\\]) for typical achalasia (Chicago classification I, II), with only the inner circular muscle layer incised.\n\nThere is still no conclusion on the thickness of muscle bundle dissection recommended during POEM. Selective circular muscle myotomy is designed to avoid gastroesophageal reflux (GER) postoperatively and decrease morbidity during POEM. But one meta-analysis showed that Heller's surgery could keep patients in long-time remission, mainly because of its full-thickness muscle bundle dissection to make sure of persist relaxation of LES. A retrospective study comparing the outcomes of full-thickness and circular muscle myotomy showed no differences in efficacy, GER or adverse events, although the procedural time was shorter in the full thickness myotomy group.\n\nFurther randomized controlled trials are warranted to assess the efficacy and safety of different modified myotomy approaches in POEM for patients with achalasia."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* diagnosed as achalasia type I or II according to the Chicago Classification Version 4.0, with an Eckardt score \\>3\n* Their age is ≥14years and ≤70 years\n* Able to give written consent\n\nExclusion Criteria:\n\n* undergone previous surgical treatments\n* had contra-indication to general anesthesia\n* previous surgery of the mediastinum, stomach, or esophagus;\n* Pregnant or lactating female\n* type III achalasia\n* current alcohol or drug addiction, mental retardation, severe congenital or acquired coagulopathy (international normalized ratio \\>1.6)\n* hepatic cirrhosis with or without portal hypertension, eosinophilic esophagitis (biopsies were performed at index endoscopy), or confirmed Barrett's esophagus\n* esophageal diverticula or hiatal hernia based on findings from the index barium esophagram, or other conditions that the investigator believed not appropriate for POEM procedure"}, 'identificationModule': {'nctId': 'NCT04578769', 'briefTitle': 'Assessment of Different Modified POEM for Achalasia', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Comparison Study of Conventional Peroral Endoscopic Myotomy (POEM) and Different Modified Procedures of POEM for Achalasia', 'orgStudyIdInfo': {'id': 'PUMCH-POEM-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'conventional myotomy', 'description': 'conventional myotomy for achalasia type I or II', 'interventionNames': ['Procedure: conventional myotomy']}, {'type': 'EXPERIMENTAL', 'label': 'full-thickness myotomy', 'description': 'modified myotomy (full-thickness myotomy) for achalasia type I or II', 'interventionNames': ['Procedure: full-thickness myotomy']}], 'interventions': [{'name': 'conventional myotomy', 'type': 'PROCEDURE', 'otherNames': ['circular myotomy', 'non-tailored myotomy'], 'description': '1. Initial mucosal incision. After submucosal injection, a reverse T entry incision is made at approximately 10 cm proximal to the gastroesophageal junction (GEJ).\n2. Submucosal tunnel establishment. A submucosal tunnel is created to 2-3 cm distal to the GEJ.\n3. Endoscopic myotomy. A selective circular muscle myotomy is carried out in a proximal to distal direction, from 2 cm distal to the mucosal entry down to 2 cm distal to the GEJ.\n4. Zippered closure of mucosal entry. The mucosal incision is closed using hemostatic clips.', 'armGroupLabels': ['conventional myotomy']}, {'name': 'full-thickness myotomy', 'type': 'PROCEDURE', 'otherNames': ['modified myotomy'], 'description': '1. Initial mucosal incision. After submucosal injection, a reverse T entry incision is made at approximately 10 cm proximal to the gastroesophageal junction (GEJ).\n2. Submucosal tunnel establishment. A submucosal tunnel is created to 2-3 cm distal to the GEJ.\n3. Endoscopic myotomy. A selective circular muscle myotomy is carried out in a proximal to distal direction, from 2 cm distal to the mucosal entry down to 4 cm proximal to the GEJ, and a full-thickness muscle myotomy is continually carried out from 4cm proximal to the GEJ down to 2 cm distal to the GEJ.\n4. Zippered closure of mucosal entry. The mucosal incision is closed using hemostatic clips.', 'armGroupLabels': ['full-thickness myotomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tao Guo, MD', 'role': 'CONTACT', 'email': 'guoqiong990@126.com', 'phone': '8610-69155017'}, {'name': 'Tao Guo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Gastroenterology, Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Tao Guo, MD', 'role': 'CONTACT', 'email': 'guoqiong990@126.com', 'phone': '8610-69155017'}], 'overallOfficials': [{'name': 'Tao Guo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated professor', 'investigatorFullName': 'Tao Guo', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}