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NCT Number: NCT06189859

Electrosurgical Modes for Endoscopic Submucosal Dissection in Peroral Endoscopic Esophageal Myotomy

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cairo University

Cairo, 11562, Egypt

Location status: Recruiting

Location contact

Hany M Shehab, FRCP

PRINCIPAL_INVESTIGATOR

Hany M Shehab, MD

CONTACT

[email protected]

01111111071

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: POEM

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

Primary outcomes

  1. Speed of endoscopic submucosal dissection

    Time frame: during the procedure

    Speed of dissection (cm/minute)

Secondary outcomes

  1. Intraprocedural Bleeding

    Time frame: during the procedure

    Bleeding necessitating change in electrosurgical mode

  2. Significant Intraprocedural bleeding

    Time frame: during the procedure

    Bleeding necessitating change of instrument to coagulating forceps

  3. Other Adverse events

    Time frame: during the procedure

    Including mucosal injury, postoperative pain, postoperative bleeding and other complications

  4. Total procedure duration

    Time frame: during the procedure

    Total procedure duration

  5. Endoscopic submucosal tunneling duration

    Time frame: during the procedure

    Endoscopic submucosal tunneling duration

Study contacts

Contact information is provided by the study sponsor or research team.

hany Shehab, MD, FRCP

CONTACT

[email protected]

+201111111071

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 5, 2024
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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