Achalasia, Achalasia Cardia
Conditions
Keywords
achalasia, POEM, ELECTROSURGERY, SPRAY COAGULATION, PERORALENDOSCOPIC ESOPHAGEAL MYOTOMY
Brief 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.
Interventions
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
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
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Allocation of patients will be in sealed envelopes to be opened on day of the procedure. The investigator and care provider (same) will thus be unmasked. Participant and outcomes assessor will remain masked until the end of the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speed of endoscopic submucosal dissection | during the procedure | Speed of dissection (cm/minute) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraprocedural Bleeding | during the procedure | Bleeding necessitating change in electrosurgical mode |
| Significant Intraprocedural bleeding | during the procedure | Bleeding necessitating change of instrument to coagulating forceps |
| Other Adverse events | during the procedure | Including mucosal injury, postoperative pain, postoperative bleeding and other complications |
| Total procedure duration | during the procedure | Total procedure duration |
| Endoscopic submucosal tunneling duration | during the procedure | Endoscopic submucosal tunneling duration |
Countries
Egypt
Contacts
Primary Contacthany Shehab, MD, FRCP
Outcome results
None listed