Transpyloric Stenting as a Predictor for G-POEM for Refractory Gastroparesis
Primary Purpose
Gastroparesis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transpyloric stent
Sham
Sponsored by
About this trial
This is an interventional treatment trial for Gastroparesis
Eligibility 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
Sites / Locations
- Northwestern UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Transpyloric stent
Sham
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Age
Assessed in years
Weight
Assessed in kilograms
Height
Assessed in inches
BMI
Assessed in kg/m^2
Adverse events
Assessed based on current American Society for Gastrointestinal Endoscopy (ASGE) guideline definitions for endoscopic adverse events
Procedure length
Assessed in minutes
Full Information
NCT ID
NCT04287647
First Posted
December 4, 2019
Last Updated
October 11, 2023
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT04287647
Brief Title
Transpyloric Stenting as a Predictor for G-POEM for Refractory Gastroparesis
Official Title
Transpyloric Stenting for Refractory Gastroparesis Prior to Gastric Per-Oral Endoscopic Myotomy: A Prospective Sham Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
June 6, 2024 (Anticipated)
Study Completion Date
June 6, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
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 gastric emptying in the absence of mechanical obstruction. Recent epidemiologic data has shown a substantial increase of 158% in hospitalizations related to gastroparesis in recent years. The pathogenesis underlying gastroparesis is complex with multiple potential underlying mechanisms including impaired gastric accommodation, autonomic neuropathy, vagal nerve injury, uncoordinated gastric contractility, and pyloric dysfunction.
Effective and durable medical treatment of gastroparesis has remained clinically challenging. Currently metoclopramide is the only medication approved by the U.S. Food and Drug Administration (FDA) for diabetic gastroparesis, and treatment courses are recommended to be limited to a maximum of 12 weeks due to the risk of the irreversible side effect of tardive dyskinesia. Surgical treatments for gastroparesis also remain limited, with sparse existing data to support the use of implanted gastric electrical stimulation for treatment of refractory gastroparesis, which is currently approved by the FDA only for compassionate use. More recently, surgical pyloroplasty has been examined in treatment of gastroparesis, which has long been recognized as a technique to improve gastric drainage for mechanical obstructions and during elective vagotomy after gastric surgery. A recent study examined surgical pyloroplasty in 28 patients with post-surgical gastroparesis with 83% patients reporting significant clinical improvement at one-month follow-up but current surgical literature remains limited in this area and has focused primarily on post-surgical gastroparesis.
Given the lack of effective treatment options, endoscopic therapies for gastroparesis have recently been investigated as adjunctive or alternative methods to treat gastroparesis. Pyloric dysfunction characterized by pyloric restriction or pylorospasm with prolonged periods of increased pyloric tone and contractions has been brought to attention as an area of targetable therapy for a subset of patients with gastroparesis. Pyloric botulinum toxin injections initially demonstrated improvement in gastric emptying after treatment, but subsequent results from double-blinded placebo-control studies failed to demonstrate a difference in symptoms compared to placebo.
Transpyloric stenting was initially reported in 2013 in three cases of refractory gastroparesis with placement of a double layered, fully-covered, Niti-S self-expandable metal stent (TaeWoong Medical) across the pylorus with improvement in gastric emptying and symptoms in all three patients. A subsequent study of 30 patients with refractory gastroparesis who underwent transpyloric stenting demonstrated high technical success of stent placement (98%) with improvement of clinical symptoms in 75% of patients and 4-hour gastric emptying studies in 69% of patients. Stent migration was found to occur in 59% of patients without any associated adverse events. Current focus on transpyloric stenting in gastroparesis centers around determining optimal stent type and method of stent anchorage as well as the role of transpyloric stenting in treatment given lack of long-term durability.
With advancements in endoscopic submucosal dissection, G-POEM has recently come in to light as a minimally invasive technique to treat refractory gastroparesis. Esophageal endoscopic myotomy has previously been well-described as a procedure for treatment of achalasia, and this technique was adopted by in 2013 with the first G-POEM for refractory gastroparesis. A subsequent multicenter study in 2017 reported on 30 patients with refractory gastroparesis who underwent G-POEM with a technical success rate of 100%. At 5.5-month follow-up, 86% of patients were found to have clinical response. Repeat gastric emptying studies after G-POEM also normalized or improved in 47% and 37% of patients respectively. G-POEM has now gained both national and international recognition in succeeding studies as a feasible and safe technique to effectively treat refractory gastroparesis in a subset of patients.
Identifying predictors of success of G-POEM for treatment of gastroparesis is essential in further recognizing appropriate patients who would benefit from this therapy. As transpyloric stenting and G-POEM share underlying mechanisms of disruption of the pylorus, the investigators propose that improvement with transpyloric stenting in patients with refractory gastroparesis can be a predictor of subsequent response with G-POEM.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
Participants and other care providers are blinded to whether they receive a transpyloric stent vs sham
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transpyloric stent
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transpyloric stent
Intervention Description
See arm/group descriptions
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
Sham
Primary Outcome Measure Information:
Title
Clinical response will be assessed by the gastroparesis cardinal symptom index (GCSI) scores
Description
GCSI assessment is based off an average of 16 questions that are scored from 0-5, with higher scores indicating a worse clinical outcome.
Time Frame
1-2 years
Secondary Outcome Measure Information:
Title
Age
Description
Assessed in years
Time Frame
1-2 years
Title
Weight
Description
Assessed in kilograms
Time Frame
1-2 years
Title
Height
Description
Assessed in inches
Time Frame
1-2 years
Title
BMI
Description
Assessed in kg/m^2
Time Frame
1-2 years
Title
Adverse events
Description
Assessed based on current American Society for Gastrointestinal Endoscopy (ASGE) guideline definitions for endoscopic adverse events
Time Frame
1-2 years
Title
Procedure length
Description
Assessed in minutes
Time Frame
intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
A. Aziz Aadam, MD
Phone
2244060582
Email
abdul.aadam@northwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin Liu, MD
Phone
6233639052
Email
kevin-liu@northwestern.edu
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A. Aziz Aadam, MD
Phone
224-406-0582
Email
abdul.aadam@northwestern.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Transpyloric Stenting as a Predictor for G-POEM for Refractory Gastroparesis
We'll reach out to this number within 24 hrs