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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spray coag mode | Active Comparator | After initial mucosal incision, Endoscopic submucosal dissection will be performed using Spray coag mode using ERBE VIO 3 generator (effect 3-3.5) |
|
| Precisect mode | Active Comparator | After initial mucosal incision, Endoscopic submucosal dissection will be performed using Precisect mode using ERBE VIO 3 generator (effect 4.5-5) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Speed of endoscopic submucosal dissection | Speed of dissection (cm/minute) | during the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Intraprocedural Bleeding | Bleeding necessitating change in electrosurgical mode | during the procedure |
| Significant Intraprocedural bleeding | Bleeding necessitating change of instrument to coagulating forceps |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| hany Shehab, MD, FRCP | Contact | +201111111071 | h.shehab@kasralainy.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| hany shehab | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Recruiting | Cairo | 11562 | Egypt |
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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.
|
|
| 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 |
|
| during the procedure |
| Other Adverse events | Including mucosal injury, postoperative pain, postoperative bleeding and other complications | during the procedure |
| Total procedure duration | Total procedure duration | during the procedure |
| Endoscopic submucosal tunneling duration | Endoscopic submucosal tunneling duration | during the procedure |
| ID | Term |
|---|---|
| D004931 | Esophageal Achalasia |
| D000084462 | Hyperthermia |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018882 | Heat Stress Disorders |
| D014947 | Wounds and Injuries |
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