Electrosurgical Modes for Endoscopic Submucosal Dissection in Peroral Endoscopic Esophageal Myotomy

Cairo University (CU)

Status and phase: Enrolling; Phase 3

Conditions: Achalasia; Achalasia Cardia

Treatments: Procedure: endoscopic submucosal dissection using Precisect mode; Procedure: endoscopic submucosal dissection using SPRAY COAG mode

Study type: Interventional

Funder types: Other

Identifiers

NCT06189859

ESRCT

Details and patient eligibility

About

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.

Enrollment: 52 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

52 participants in 2 patient groups

Spray coag mode

Active Comparator group

Description:

After initial mucosal incision, Endoscopic submucosal dissection will be performed using Spray coag mode using ERBE VIO 3 generator (effect 3-3.5)

Treatment:

Procedure: endoscopic submucosal dissection using SPRAY COAG mode

Precisect mode

Active Comparator group

Description:

After initial mucosal incision, Endoscopic submucosal dissection will be performed using Precisect mode using ERBE VIO 3 generator (effect 4.5-5)

Treatment:

Procedure: endoscopic submucosal dissection using Precisect mode