A randomized clinical trial comparing endoscopic per-oral pyloromyotomy (POP) versus a control sham intervention (diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption) in patients with medically refractory gastroparesis.
A comparative effectiveness, single center (with two surgical units), randomized (1:1) study of endoscopic per-oral pyloromyotomy (POP) versus a control sham intervention (diagnostic esophagogastroduodenoscopy (EGD) without pyloric disruption) in adult patients with medically refractory gastroparesis who have failed management with dietary, lifestyle, and pharmacological therapy for at least six months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Per-oral pyloromyotomy (POP), alternatively knows as gastric per-oral endoscopic myotomy (G-POEM), accomplishes longitudinal division of the pylorus using an endoscope. This procedure involves utilizing endoscopic electrosurgical knife to make an incision in the gastric mucosa and develop a submucosal tunnel to visualize the pyloric ring. The pyloric ring is divided longitudinally, and the mucosotomy incision is sealed with endoscopic clips.
While under general anesthesia, a standard gastroscope is introduced and a diagnostic upper endoscopy is performed. The operator talks through the procedure steps as if completing POP. The gastroscope is withdrawn and the patient is extubated.
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Gastroparesis Cardinal Symptom Index (GCSI)
Change in Gastroparesis Cardinal Symptom Index (GCSI) at Baseline to 12 weeks post-procedure. Possible scores range from 0 (None) to 5 (Very Severe).
Time frame: Baseline, 12 weeks post-procedure
Gastric Emptying
Change in gastric emptying as measured by a standardized 4-hour solid scintigraphic gastric emptying study at Baseline to 12 weeks post-procedure
Time frame: Baseline, 12 weeks post-procedure
36-Item Short Form; Quality of Life Survey
Change in 36-Item Short Form Survey (SF-36) score from Baseline to 12 weeks post-procedure. The weighted sums of responses to questions in the survey produce eight separate scales which are scored from 0-100, with zero indication maximum disability and one hundred indicating no disability in that domain.
Time frame: Baseline,12 weeks post-procedure
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