Transpyloric Stenting As a Predictor for G-POEM for Refractory Gastroparesis
Transpyloric Stenting for Refractory Gastroparesis Prior to Gastric Per-Oral Endoscopic Myotomy: a Prospective Sham Study
Northwestern University
36 participants
May 15, 2019
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- 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 Criteria6
- Patients with prior history of gastroenteric anastomosis or any GI surgeries with pyloric involvement
- Patients with gastroesophageal malignancy
- 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
- Patients with uncorrectable coagulopathy defined by INR >1.5 or platelets <50
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Interventions
See arm/group descriptions
Sham
Locations(1)
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NCT04287647