Electrosurgical Modes for Endoscopic Submucosal Dissection in Peroral Endoscopic Esophageal Myotomy

Electrosurgical Modes for Endoscopic Submucosal Dissection in Peroral Endoscopic Esophageal Myotomy: a Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Achalasia; Achalasia Cardia
• Intervention / Treatment: Procedure: endoscopic submucosal dissection using SPRAY COAG mode; Procedure: endoscopic submucosal dissection using Precisect mode

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Hany Shehab, MD, FRCP; Phone Number: +201111111071; Email: h.shehab@kasralainy.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Recruiting
    • Cairo University
    • Contact: Hany M Shehab, MD; Phone Number: 01111111071; Email: H.shehab@kasralainy.edu.eg
    • Principal Investigator: Hany M Shehab, FRCP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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)	Procedure: endoscopic submucosal dissection using SPRAY COAG mode; After initial mucosal incision, submucosal dissection will be performed down to 2cm below the cardia using Spray coag mode using ERBE VIO3 generator and a Hybrid knife (T-type) aided by ERBEJET for submucosal injection; Other Names: POEM
Active Comparator: Precisect mode; After initial mucosal incision, Endoscopic submucosal dissection will be performed using Precisect mode using ERBE VIO 3 generator (effect 4.5-5)	Procedure: endoscopic submucosal dissection using Precisect mode; After initial mucosal incision, submucosal dissection will be performed down to 2cm below the cardia using Precisect mode using ERBE VIO3 generator and a Hybrid knife (T-type) aided by ERBEJET for submucosal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speed of endoscopic submucosal dissection	Speed of dissection (cm/minute)	during the procedure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: hany shehab, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: December 19, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2025
• Last Update Submitted That Met QC Criteria: May 8, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: POEM; achalasia; ELECTROSURGERY; SPRAY COAGULATION; PERORALENDOSCOPIC ESOPHAGEAL MYOTOMY
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Achalasia
• Other Study ID Numbers: ESRCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No