Electrosurgical Modes for Endoscopic Submucosal Dissection in Peroral Endoscopic Esophageal Myotomy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCairo University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing POEM procedure for any esophageal motility disorder
Esophageal motility disorder confirmed by high-resolution manometry and gastroscopy
Disqualifiers
Esophageal varices
Esophageal neoplasms
Non-correctable coagulopathy
Failure to provide an informed consent
Trial design
Design model
Parallel
Treatments tested in this trial
endoscopic submucosal dissection using SPRAY COAG mode
Procedure/SurgeryAfter 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
Procedure/SurgeryAfter 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
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: Spray coag modeActive comparator 1 intervention
Group B: Precisect modeActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Speed of endoscopic submucosal dissection
Speed of dissection (cm/minute)
Time frame
during the procedureSecondary outcomes
1
Intraprocedural Bleeding
Bleeding necessitating change in electrosurgical mode
Time frame
during the procedure2
Significant Intraprocedural bleeding
Bleeding necessitating change of instrument to coagulating forceps
Time frame
during the procedure3
Other Adverse events
Including mucosal injury, postoperative pain, postoperative bleeding and other complications
Time frame
during the procedure4
Total procedure duration
Total procedure duration
Time frame
during the procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov