RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Transpyloric Stenting for Refractory Gastroparesis Prior to Gastric Per-Oral Endoscopic Myotomy: A Prospective Sham Study

Quick Facts

Study Start:2019-05-15
Study Completion:2024-06-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04287647

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * Patients with diabetic, idiopathic or post-surgical gastroparesis
  3. * 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)
  1. * Patients with prior history of gastroenteric anastomosis or any GI surgeries with pyloric involvement
  2. * Patients with gastroesophageal malignancy
  3. * Patients who are unable to tolerate upper endoscopy secondary to cardiopulmonary instability or other contraindications to endoscopy
  4. * Patients with cirrhosis
  5. * Patients who are pregnant or breastfeeding
  6. * Patients with uncorrectable coagulopathy defined by INR \>1.5 or platelets \<50

Contacts and Locations

Study Contact

A. Aziz Aadam, MD
CONTACT
2244060582
abdul.aadam@northwestern.edu
Kevin Liu, MD
CONTACT
6233639052
kevin-liu@northwestern.edu

Study Locations (Sites)

Northwestern University
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-05-15
Study Completion Date2024-06-06

Study Record Updates

Study Start Date2019-05-15
Study Completion Date2024-06-06

Terms related to this study

Additional Relevant MeSH Terms

  • Gastroparesis