Electrosurgical Modes for Endoscopic Submucosal Dissection in Peroral Endoscopic Esophageal Myotomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: endoscopic submucosal dissection using SPRAY COAG mode, endoscopic submucosal dissection using Precisect mode.
- Who it may be relevant to
- Registry conditions: Achalasia, Achalasia Cardia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Electrosurgical Modes for Endoscopic Submucosal Dissection in Peroral Endoscopic Esophageal Myotomy: a Randomized Controlled Trial
Overview
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.
Interventions
- 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 - Procedure 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
Primary outcome measures
- Speed of endoscopic submucosal dissection [Time frame: during the procedure]
Secondary outcome measures (5)
- Intraprocedural Bleeding [Time frame: during the procedure]
- Significant Intraprocedural bleeding [Time frame: during the procedure]
- Other Adverse events [Time frame: during the procedure]
- Total procedure duration [Time frame: during the procedure]
- Endoscopic submucosal tunneling duration [Time frame: during the procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Cairo University — Cairo
Identifiers
NCT: NCT06189859 · ESRCT