Electrosurgical Modes for Endoscopic Submucosal Dissection in Peroral Endoscopic Esophageal Myotomy

Achalasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06189859
• Other study ID #: ESRCT
• Status: Recruiting
• Phase: Phase 3
• Start date: March 16, 2024
• Est. completion date: August 2025

Study information

• Verified date: March 2024
• Source: Cairo University
• Contact: hany Shehab, MD, FRCP
• Phone: +201111111071
• Email: h.shehab[@]kasralainy.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: August 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Achalasia
• Achalasia Cardia
• Esophageal Achalasia

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speed of endoscopic submucosal dissection	Speed of dissection (cm/minute)	during the procedure
Secondary	Intraprocedural Bleeding	Bleeding necessitating change in electrosurgical mode	during the procedure
Secondary	Significant Intraprocedural bleeding	Bleeding necessitating change of instrument to coagulating forceps	during the procedure
Secondary	Other Adverse events	Including mucosal injury, postoperative pain, postoperative bleeding and other complications	during the procedure
Secondary	Total procedure duration	Total procedure duration	during the procedure
Secondary	Endoscopic submucosal tunneling duration	Endoscopic submucosal tunneling duration	during the procedure