Transpyloric Stenting As a Predictor for G-POEM for Refractory Gastroparesis

NCT04287647 | Recruiting DMC FDA Device

• 1 other identifier: STU00209539
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Gastroparesis

Outcome Measures

Primary Outcomes (1)

• Clinical response will be assessed by the gastroparesis cardinal symptom index (GCSI) scores

  GCSI assessment is based off an average of 16 questions that are scored from 0-5, with higher scores indicating a worse clinical outcome.

  1-2 years

Secondary Outcomes (6)

• Age

  1-2 years

• Weight

  1-2 years

• Height

  1-2 years

• BMI

  1-2 years

• Adverse events

  1-2 years

Study Arms (2)

Transpyloric stent

ACTIVE COMPARATOR

In this group, patient's will be randomized to receive a transpyloric stent for treatment of refractory gastroparesis. They will be blinded for one month after stent placement as to whether they received a stent or sham.

Device: Transpyloric stent

Sham

SHAM COMPARATOR

In this group, patient's will be randomized to sham for treatment of refractory gastroparesis. They will be blinded for one month after stent placement as to whether they received a stent or sham.

Other: Sham

Interventions

Transpyloric stent DEVICE

See arm/group descriptions

Transpyloric stent

Sham OTHER

Sham

Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Gastroparesis

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

A. Aziz Aadam, MD

CONTACT

2244060582; abdul.aadam@northwestern.edu

Kevin Liu, MD

CONTACT

6233639052; kevin-liu@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants and other care providers are blinded to whether they receive a transpyloric stent vs sham
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: February 27, 2020
• Study Start: May 15, 2019
• Primary Completion (Estimated): June 6, 2026
• Study Completion (Estimated): June 6, 2026
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)