Status:
RECRUITING
Transpyloric Stenting As a Predictor for G-POEM for Refractory Gastroparesis
Lead Sponsor:
Northwestern University
Conditions:
Gastroparesis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 pyloromyoto...
Detailed Description
Gastroparesis is defined as a complex syndrome of symptoms including early satiety, post-prandial fullness, nausea, vomiting, bloating, and upper abdominal pain with a corresponding objective delay in...
Eligibility Criteria
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 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
Key Trial Info
Start Date :
May 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 6 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04287647
Start Date
May 15 2019
End Date
June 6 2026
Last Update
February 17 2025
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611