RecruitingPhase 3NCT06189859

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


Sponsor

Cairo University

Enrollment

52 participants

Start Date

Mar 16, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

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

Exclusion Criteria4

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

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Interventions

PROCEDUREendoscopic 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

PROCEDUREendoscopic 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(1)

Cairo University

Cairo, Egypt

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NCT06189859


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