[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617934":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":39,"centralContacts":44,"locations":30,"responsibleParty":51,"collaborators":30,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":30,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":30,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":30,"overallStatus":74,"whyStopped":30,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":80,"leadSponsor":82,"locationsCount":30},{"fullName":5,"class":6},"Asian Institute of Gastroenterology, India","OTHER",[8,13,20],{"label":9,"type":6,"description":10,"interventionNames":11},"Arm A (Control Group)","Conventional POEM with 10-12 cm submucosal tunnel, 6-8 cm Esophageal myotomy, and 2 cm gastric myotomy",[12],"Procedure: Arm A - Conventional POEM (Control Arm)",{"label":14,"type":15,"description":16,"interventionNames":17},"Arm B (Standard Submucosal Tunnel + EGJ - complex only Myotomy)","ACTIVE_COMPARATOR","10-12 cm submucosal tunnel with myotomy restricted to the EGJ (2 cm Esophageal and 2 cm gastric)",[18,19],"Procedure: Arm B - Standard Tunnel with EGJ complex-only Myotomy","Procedure: Arm C - Ultra-short Tunnel POEM with EGJ complex -only Myotomy",{"label":21,"type":15,"description":22,"interventionNames":23},"Arm C (Ultra-short Tunnel + EGJ- complex only Myotomy)","4 cm submucosal tunnel with myotomy focused on the EGJ (2 cm Esophageal and 2 cm gastric)",[18,19],[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"PROCEDURE","Arm A - Conventional POEM (Control Arm)","Arm A - Conventional POEM (Control Arm)\n\n* Tunnel Length: 10-12 cm submucosal tunnel, extending from 10 cm proximal to the EGJ into the proximal stomach.\n* Myotomy:\n\n  * Esophageal segment: 6-8 cm\n  * Gastric segment: 2 cm\n  * Myotomy orientation: posterior (5-6 o'clock position)\n  * Depth: selective circular myotomy in Esophageal segment, full-thickness at LES and gastric side",[9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Arm B - Standard Tunnel with EGJ complex-only Myotomy","* Tunnel Length: 10-12 cm submucosal tunnel to allow full-length inspection and safe scope manipulation.\n* Myotomy:\n\n  * Esophageal: 2 cm proximal to EGJ\n  * Gastric: 2 cm distal to EGJ\n  * Purpose: limit disruption of Esophageal muscle above EGJ while retaining effective LES division\n  * Myotomy is confined to the EGJ complex while still using a standard tunnel\n  * Full-thickness myotomy may be used at the EGJ for consistency",[14,21],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Arm C - Ultra-short Tunnel POEM with EGJ complex -only Myotomy","* Tunnel Length: Approximately 4 cm, just enough to reach the EGJ complex and enable targeted dissection\n* Myotomy:\n\n  * Esophageal: 2 cm\n  * Gastric: 2 cm\n  * Only the EGJ segment is divided, minimising disruption of proximal Esophageal musculature\n  * Myotomy is performed selectively along the posterior axis (5-6 o'clock) Intraoperative Assessment and Quality Control\n* Adequacy of gastric extension is confirmed with visualisation of retroflexed scope or via second scope trans illumination when needed.\n* Any bleeding is controlled with coagulation graspers or cautery.\n* Tunnelling is performed closely along the Muscularis propria to minimise mucosal injury.\n* The scope is periodically withdrawn for mucosal inspection during the procedure.",[14,21],[40],{"name":41,"affiliation":42,"role":43},"Dr.Mohan Kumar Ramchandani, MD, DM","AIG Hospitals","STUDY_DIRECTOR",[45],{"name":46,"role":47,"phone":48,"phoneExt":49,"email":50},"Dr.Aniruddha Pratap singh, MD, DM","CONTACT","9004093248","+91","Doc.aniruddha85@gmail.com",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Mohan Ramchandani","MD, DM, FJGES , Director interventional Endoscopy , senior consultant Gastroenterologist","100617934","comparison-of-conventional-and-short-submucosal-tunnel-techniques-in-type-ii-achalasia-100617934",false,"NCT07325071","Comparison of Conventional and Short Submucosal Tunnel Techniques in Type II Achalasia","A Randomized Controlled Trial Comparing Conventional and Short Submucosal Tunnel Techniques in Type II Achalasia","Inclusion Criteria:\n\n1. Adults aged \\>18 years.\n2. Diagnosis of Type II achalasia naïve patients based on high-resolution manometry (Chicago Classification v4).\n3. Eckardt score \\>3.\n4. Written informed consent\n\nExclusion Criteria:\n\n1. Type I or III achalasia.\n2. Previous endoscopic or surgical treatment for achalasia.\n3. Contraindications for POEM (e.g., coagulopathy, portal hypertension).\n4. Sigmoid Achalasia","ALL","19 Years","75 Years",{"count":66,"type":67},636,"ESTIMATED","INTERVENTIONAL",[70],"NA","Rationale for This Study The primary rationale for this study is to evaluate whether a shorter submucosal tunnel during POEM with an EGJ-focused myotomy in type II Achalasia cardia patients, provides equivalent or superior symptom relief compared to the conventional approach while minimizing adverse events such as GERD \\& blown out myotomy and decreasing the procedure time.\n\nObjectives\n\nPrimary Objective:\n\nTo compare the incidence of GERD (with manual review) at 3 and 12 months' post-procedure between conventional POEM and two experimental short-tunnel POEM techniques in patients with Type II achalasia.\n\nSecondary Objectives:\n\nTo evaluate\n\n1. Clinical success based on Eckardt score\n2. Operating total procedure time\n3. Use of Acid Suppressants on Follow up at 1 year\n4. Severity of Esophagitis at 3 months\n5. Intraoperative \\& Postoperative adverse events (AGREE classification),\n6. GERD-HRQL (0-18) scores 3 \\& 12 Months\n7. (Clinically relevant GORD was defined as excessive oesophageal \u002FAET associated with a GERDQ score \\>7 and\u002For with any grade of reflux oesophagitis).\n8. Duration of Hospital stay\n9. Quality of life (SF36)",[73],"Esophageal Diseases","NOT_YET_RECRUITING","2025-12-31",{"date":77,"type":78},"2026-01-08","ACTUAL",{"date":75,"type":67},{"date":81,"type":67},"2027-07-30",{"name":5,"class":6}]