Clinical trial NCT05272046: Monopolar and Bipolar Current RFA Knife in POEM
Official title: Comparison of the Performance of Monopolar Current Cutting Knife and Bipolar RFA Knife in POEM (Per-Oral Endoscopic Myotomy)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Esophageal Motility Disorders
Keywords: Achalasia
Dysphagia
Per-Oral Endoscopic Myotomy
Bipolar electrocautery
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2022-03-09
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups with patients randomized into receiving either the standard of care bipolar electrocautery tool or monopolar electrocautery tool.
Primary purpose: OTHER

Brief summary: Per Oral Endoscopic Myotomy (POEM) is performed for various esophageal muscular disorders, including achalasia and other spastic esophageal conditions. It is performed with the standard endoscope and involves dissecting the esophageal muscle sphincter. The procedure is typically completed using standard monopolar energy, which are effective, but can be associated with post-procedural pain. More importantly, frequent exchange of various instruments are required in order to cut the right layers and to stop bleeding. The Speedboat-RSD is FDA approved for dissection of various tissue within the gastrointestinal tract tract but only a few studies have evaluated its use in POEM. Currently, the investigators have been performing EGD with POEM procedures using Speedboat-RSD as a standard of care procedure. The investigators would like to compare the performance of the standard monopolar ERBE knife to the bipolar Speedboat-RSD knife in POEM. The investigators hypothesize the bipolar knife will allow for efficient completion of the POEM procedure with less post procedural pain.

Detailed description: Per Oral Endoscopic Myotomy (POEM) is performed for various esophageal motility disorders, including achalasia and other spastic esophageal conditions. It is performed with the standard endoscope and involves dissection of the esophageal submucosa followed by cutting of the esophageal muscle. The procedure is typically completed using standard monopolar cutting knives, which are effective, but can be associated with inadvertent thermal injury and post-procedural pain due to dissemination of higher voltage. More importantly, frequent exchange of various instruments are required in order to inject within the submucosa and to coagulate bleeding vessels. The Speedboat-RSD has an integrated injection needle for submucosal injection and uses bipolar radiofrequency energy (BRF) and microwave energy to dissect tissue/coagulate vessels. In essence, injection, submucosal dissection, cutting, and coagulation can all occur with one knife (2). It is FDA approved for submucosal dissection (ESD) and myotomy within the gastrointestinal tract but only a few studies have evaluated its use in POEM (3). Currently, the investigators have been performing EGD with the POEM procedure using Speedboat-RSD as a standard of care procedure. The investigators would like to compare the performance of the standard monopolar ERBE knife to the bipolar Speedboat-RSD knife in POEM. The investigators hypothesize the bipolar knife will allow for efficient completion of the POEM procedure with less post-procedural related pain.

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years of age
* Able to sign consent - Planned POEM procedure for all indications

Exclusion Criteria:

* Pregnant patients
* Prisoners
* Unable to sign consent

Primary outcomes:
measure: Change in pain score
timeFrame: Pre-procedure, 1-hour post procedure, 8-10 hours post procedure, and 24 hours post procedure.
Secondary outcomes:
measure: Technical success rate of patients who completed POEM procedure with the bipolar knife.
timeFrame: Day 1
measure: Total procedure time (minutes)
timeFrame: Day 1
measure: Study knife removal during procedure
timeFrame: Day 1
measure: Hospital Length-of-stay
timeFrame: Up to 1 week
measure: Adverse events
timeFrame: 1 month, 3 months, 6 months, and 12 months.
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology (AIG) Hospitals
city: Pamplona
country: Spain
facility: Navarra Hospital Complex - Navarra Hospital
Study officials:
References:
citation: Jung D, Youn YH, Jahng J, Kim JH, Park H. Risk of electrocoagulation syndrome after endoscopic submucosal dissection in the colon and rectum. Endoscopy. 2013 Sep;45(9):714-7. doi: 10.1055/s-0033-1344555. Epub 2013 Aug 29.
citation: Saunders B P, Tsiamoulos Z P, Bourikas L et al.The
citation: Patil G, Dalal A, Maydeo AP. Feasibility of Speedboat RS2 with bipolar radiofrequency energy for peroral endoscopic myotomy in patients with achalasia (with video). Endosc Int Open. 2020 Aug;8(8):E998-E1001. doi: 10.1055/a-1165-0087. Epub 2020 Jul 21.