Using transpyloric stenting to predict success of G-POEM for gastroparesis
Transpyloric Stenting for Refractory Gastroparesis Prior to Gastric Per-Oral Endoscopic Myotomy: a Prospective Sham Study
This study is testing if a special stent can help predict how well a new procedure called G-POEM will work for adults with gastroparesis who haven't found relief from other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northwestern University Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT04287647 on ClinicalTrials.gov |
What this trial studies
This study investigates whether transpyloric stenting with a lumen apposing metal stent (LAMS) can predict clinical response to gastric per-oral endoscopic pyloromyotomy (G-POEM) in patients with refractory gastroparesis. It is a prospective sham study that aims to determine if improvement from transpyloric stenting correlates with successful outcomes from G-POEM. Gastroparesis is a challenging condition characterized by delayed gastric emptying and various gastrointestinal symptoms, and current treatment options are limited. The study will include adult patients diagnosed with gastroparesis who have not responded to standard medical therapies.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with refractory gastroparesis due to diabetic, idiopathic, or post-surgical causes.
Not a fit: Patients with prior gastroenteric surgeries involving the pylorus or those with malignancies or severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new predictive tool for determining which patients may benefit from G-POEM, potentially improving treatment outcomes for refractory gastroparesis.
How similar studies have performed: While the approach of using transpyloric stenting is relatively novel, similar studies exploring surgical interventions for gastroparesis have shown varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Chicago, Illinois
- Northwestern University — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: A. Aziz Aadam, MD
- Email: abdul.aadam@northwestern.edu
- Phone: 2244060582
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.