Electrosurgical Modes for Endoscopic Submucosal Dissection in Peroral Endoscopic Esophageal Myotomy

Phase 3

Recruiting

• Conditions: Achalasia; Achalasia Cardia
• Interventions: Procedure: endoscopic submucosal dissection using SPRAY COAG mode; Procedure: endoscopic submucosal dissection using Precisect mode

• Registration Number: NCT06189859
• Lead Sponsor: Cairo University

Brief Summary

Peroral endoscopic esophagel myotomy (POEM) is a third space endoscopy technique that depends on creating a submucosal tunnel to expose the esophageal muscle and eventually perform an esophageal myotomy. Submucosal dissection can be performed using numerous electrosurgical modes. Spray coagulation has been anecdotally favored by many endoscopists due to its high coagulation power and assumed safety. Recently, Precisect mode has been developed, it has theoretical advantages of very minimal tissue penetration and minimal to no charring effect. In this trial, the investigators compare the efficacy and safety of both electrosurgical modes in POEM procedures.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-19
• Study First Submitted QC: 2023-12-19
• Study First Posted: 2024-01-05
• Status Verified: 2024-03
• Study Start: 2024-03-16
• Last Update Submitted: 2024-03-16
• Last Update Posted: 2024-03-19
• Primary Completion: 2025-07
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Patients undergoing POEM procedure for any esophageal motility disorder
• Esophageal motility disorder confirmed by high-resolution manometry and gastroscopy

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Exclusion Criteria

• Esophageal varices
• Esophageal neoplasms
• Non-correctable coagulopathy
• Failure to provide an informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spray coag mode	endoscopic submucosal dissection using SPRAY COAG mode	After initial mucosal incision, Endoscopic submucosal dissection will be performed using Spray coag mode using ERBE VIO 3 generator (effect 3-3.5)
Precisect mode	endoscopic submucosal dissection using Precisect mode	After initial mucosal incision, Endoscopic submucosal dissection will be performed using Precisect mode using ERBE VIO 3 generator (effect 4.5-5)

Primary Outcome Measures

Name	Time	Method
Speed of endoscopic submucosal dissection	during the procedure	Speed of dissection (cm/minute)

Secondary Outcome Measures

Name	Time	Method
Intraprocedural Bleeding	during the procedure	Bleeding necessitating change in electrosurgical mode
Significant Intraprocedural bleeding	during the procedure	Bleeding necessitating change of instrument to coagulating forceps
Other Adverse events	during the procedure	Including mucosal injury, postoperative pain, postoperative bleeding and other complications
Total procedure duration	during the procedure	Total procedure duration
Endoscopic submucosal tunneling duration	during the procedure	Endoscopic submucosal tunneling duration

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt