Electrosurgical Modes for Endoscopic Submucosal Dissection in Peroral Endoscopic Esophageal Myotomy

NCT06189859 | Recruiting Phase 3

• 1 other identifier: ESRCT
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Achalasia; Achalasia Cardia

Keywords

achalasia; POEM; ELECTROSURGERY; SPRAY COAGULATION; PERORALENDOSCOPIC ESOPHAGEAL MYOTOMY

Outcome Measures

Primary Outcomes (1)

• Speed of endoscopic submucosal dissection

  Speed of dissection (cm/minute)

  during the procedure

Secondary Outcomes (5)

• Intraprocedural Bleeding

  during the procedure

• Significant Intraprocedural bleeding

  during the procedure

• Other Adverse events

  during the procedure

• Total procedure duration

  during the procedure

• Endoscopic submucosal tunneling duration

  during the procedure

Study Arms (2)

Spray coag mode

ACTIVE COMPARATOR

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

Precisect mode

ACTIVE COMPARATOR

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

Interventions

endoscopic submucosal dissection using SPRAY COAG mode PROCEDURE

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

Also known as: POEM

Spray coag mode

endoscopic submucosal dissection using Precisect mode PROCEDURE

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

Precisect mode

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 11562, Egypt

RECRUITING

MeSH Terms

Conditions

Esophageal Achalasia; Hyperthermia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Study Officials

• hany shehab

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

hany Shehab, MD, FRCP

CONTACT

+201111111071; h.shehab@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Allocation of patients will be in sealed envelopes to be opened on day of the procedure. The investigator and care provider (same) will thus be unmasked. Participant and outcomes assessor will remain masked until the end of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 5, 2024
• Study Start: March 16, 2024
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)