Transpyloric Stenting as a Predictor for G-POEM for Refractory Gastroparesis
Reason given: Excessive stent migration.
Key facts
- Where
- Chicago, United StatesSee the site
Where in United States
- Northwestern UniversityChicago, United StatesNo longer taking part
Trial details
- Who runs it
- Northwestern University
- Trial code
- NCT04287647
- Record updated
- 1 June 2026
- Original description
This is a prospective sham study to investigate the role of transpyloric stenting with lumen apposing metal stent (LAMS) as a predictor for clinical response to gastric per-oral endoscopic pyloromyotomy (GPOEM) for refractory gastroparesis. The study hypothesizes that clinical improvement with transpyloric stenting in patients with refractory gastroparesis is a predictor of subsequent clinical success of GPOEM.Read full original descriptionShow less
Transpyloric Stenting for Refractory Gastroparesis Prior to Gastric Per-Oral Endoscopic Myotomy: A Prospective Sham Study
This is a prospective sham study to investigate the role of transpyloric stenting with lumen apposing metal stent (LAMS) as a predictor for clinical response to gastric per-oral endoscopic pyloromyotomy (GPOEM) for refractory gastroparesis. The study hypothesizes that clinical improvement with transpyloric stenting in patients with refractory gastroparesis is a predictor of subsequent clinical success of GPOEM.
Inclusion: Adult patients greater than 18 years of age with gastroparesis refractory to standard medical therapy (lifestyle and diet modifications, prokinetics) or contraindication to standard therapies (e.g. allergies to prokinetic agents); Patients with diabetic, idiopathic or post-surgical gastroparesis; Patients with confirmed diagnosis of gastroparesis via gastric emptying study (abnormal gastric emptying will be defined as ≥10 % residual activity at 4 h on a standardized nuclear medicine TC-99 m sulfur colloid solid-phase gastric emptying study).
Exclusion: Patients with prior history of gastroenteric anastomosis or any GI surgeries with pyloric involvement; Patients with gastroesophageal malignancy; Patients with uncorrectable coagulopathy defined by INR >1.5 or platelets <50; Patients who are unable to tolerate upper endoscopy secondary to cardiopulmonary instability or other contraindications to endoscopy; Patients with cirrhosis; Patients who are pregnant or breastfeeding.