Combined Role of Gastric Peroral Endoscopic Myotomy and Gastric Electrical Stimulator

N/AActive Not RecruitingNCT07526935

Baylor Research Institute40 enrolled

Overview

This study is looking at how safe and effective G-POEM, GES and a combination of both are for people with severe stomach problems (gastroparesis) that haven't gotten better with medicine.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Gastroparesis

Interventions

GES + Upper endoscopyDEVICE

Participants will receive implantation of a gastric electrical stimulator (GES) with upper endoscopy (which is routine during GES placement), without undergoing G-POEM. The stimulator will remain off for the first 6 months and will then be turned on for the following 6 months.

GES on + Upper endscopyDEVICE

Participants will receive implantation of a gastric electrical stimulator (GES) with upper endoscopy (which is routine during GES placement), without undergoing G-POEM. The stimulator will stay on for the first 6 months and will then be turned off for the following 6 months.

GES off + G-POEMPROCEDURE

Participants will receive implantation of a gastric electrical stimulator (GES) with upper endoscopy (which is routine during GES placement) and G-POEM surgery. The stimulator will remain off for the first 6 months and will then be turned on for the following 6 months.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients of age 18 years and older * Patients must be able to consent * Documented diagnosis of refractory GP as determined by the following criteria: * Medically refractory GP symptoms for \> 1 year despite treatment with first-line modalities and pharmacotherapies with anti-emetics and prokinetics AND * Gastric emptying scintigraphy showing delayed gastric emptying with retention of \>60% at 2h and/or greater than 10% at 4h based on standardized radionuclide solid meal test * Preoperative Gastroparesis Cardinal Symptom Index (GCSI) Score * A decision to treat patient with surgical therapy of G-POEM and/or electric stimulator Exclusion Criteria: * Patients with prior surgical intervention for gastroparesis * Patients less than 18 years old * Pregnant women

Locations (1)

Baylor University Medical Center

Dallas, Texas, United States

Outcomes

Primary Outcomes

Gastroparesis Symptom Changes

Monitoring changes in gastroparesis symptom severity as measured by the Gastroparesis Cardinal Symptom Index (GCSI). A 9-item patient reported questionnaire with a rating scale of 0-5 ranging from 0 (none) to 5 (very severe).

Time frame: Baseline, Preoperative 3 months, 6 months, 9 months, 12 months

Secondary Outcomes

Subjects quality of life

Measuring changes to Quality of Life as measured by the 36-Item Short Form Survey (SF-36). A self-reported tool consisting of 36 questions with a rating scale of 0 (worst health) to 100 (best health).

Time frame: Baseline, 6 months, 12 months.

Weight

Assessing changes in weight using clinical measurement

Time frame: Baseline, 6 months, 12 months

BMI

Assessing changes in BMI using clinical measurement

Time frame: Baseline, 6 months, 12 months

Nutritional Support Status

Assessing for need for tube feeds/TPN by referring to subjects medical records

Time frame: Baseline, 6 months, 12 months

Gastroparesis-related hospitalizations

Evaluating rates of reintervention/hospitalizations due to surgical complications by referring to subjects medical records

Time frame: 12 month follow-up

ED visits for symptoms

Evaluating number of ED visits, hospitalizations/readmissions due to gastroparesis by referring to subjects medical records

Time frame: 12 month follow-up

Data from ClinicalTrials.gov

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