G-POEM for Treatment of Refractory Gastroparesis

Status Completed

Clinical Trial Summary

This study is performed to assess the efficacy and outcomes of Gastric Per Oral Endoscopic Myotomy "G-POEM" in patients presenting with gastroparesis.

Clinical Trial Description

Gastroparesis is a chronic digestive disorder best defined as severe nausea, vomiting, bloating, and abdominal pain in the setting of objectively delayed gastric emptying without mechanical gastric outlet obstruction. The most common etiology is idiopathic. Some of the identifiable etiologies include diabetes and post-surgical.

Endoscopic techniques to reduce pyloric tone mainly consisted of Botulinum toxin injection but failed to demonstrate significant symptom improvement compared to placebo. Another endoscopic method was transpyloric stenting which yielded symptomatic relief but is prone to stent migration and therefore is unlikely to provide a viable long term solution.

Surgical pyloroplasty has shown to be effective in reducing gastroparesis symptoms, but is associated with a risk of leakage and potential further narrowing of gastric outlet. It also carried all the risks of general anesthesia and requires advanced laparoscopic suturing skills. Therefore, the development of a less invasive reliable method of improving gastric emptying is highly desirable.

An endoscopic submucosal myotomy technique may be applied to divide the pyloric sphincter without surgical access. Such endoscopic technique may provide the benefits of a natural orifice procedure, and improve gastric emptying in gastroparetic patients. Gastric Per-Oral Endoscopic Myotomy (G-POEM) is feasible and can be performed by using techniques similar to those of esophageal per-oral endoscopic myotomy. Endoscopists who are experienced in esophageal per-oral endoscopic myotomy should be able to perform G-POEM because both use similar techniques, principles, and equipment.

The investigators theorize that a subset of patients with refractory gastroparesis, diabetic gastroparesis or post-surgical gastroparesis, may respond to endoscopic pyloromyotomy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02732821
Study type	Observational
Source	Johns Hopkins University
Contact
Status	Completed
Phase
Start date	May 2015
Completion date	April 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01557296` - Evaluation of Diagnostic Methods and Dietary Treatment of Diabetic Gastroparesis	Phase 2
Withdrawn	`NCT03376399` - Potential Benefits of Sleeve Gastrectomy Surgery on Diabetic Gastroparesis Symptoms
Not yet recruiting	`NCT02264587` - Effects and Mechanism of Mosapride Citrate on Diabetic Gastroparesis	Phase 4
Completed	`NCT02289846` - Trial of IW-9179 in Patients With Diabetic Gastroparesis (DGP)	Phase 2
Completed	`NCT03544229` - A Study to Evaluate the Efficacy and Safety of TAK-906 in Adult Participants With Symptomatic Idiopathic or Diabetic Gastroparesis	Phase 2
Recruiting	`NCT04706832` - Thoracic Splanchnic Magnetic Neuromodulation Therapy (ThorS-MagNT) for Grade 3 Diabetic Gastroparesis: Pilot Study	N/A
Not yet recruiting	`NCT05584462` - Gastroparesis in type2 Diabetic Patient
Enrolling by invitation	`NCT05812339` - Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Completed	`NCT01030341` - Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis	N/A
Recruiting	`NCT05832151` - A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adults With Diabetic Gastroparesis	Phase 2
Completed	`NCT02025725` - Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Women With Diabetic Gastroparesis	Phase 3
Completed	`NCT01916460` - Intraluminal Endosonography for Examination of the Structural Changes of the Stomach in Gastroparetic Patients	N/A
Completed	`NCT01469286` - Transcutaneous Electroacupuncture for Gastroparesis	Phase 1
Terminated	`NCT00874133` - The Effect of Acupuncture on Symptoms, Gastric Emptying Rate and Glucose Control in Patients With Diabetic Gastroparesis	N/A
Completed	`NCT01126034` - Improving Metoclopramide Prescribing Practices at Penn Through a Physician-targeted Intervention	N/A
Recruiting	`NCT05273788` - Thoracic Neuromodulation for Diabetic Gastroparesis	N/A
Suspended	`NCT00470795` - Acupuncture for Diabetic Gastroparesis	Phase 3
Completed	`NCT00139893` - A Randomized, Open-label, Two-way Crossover Trial to Determine the Pharmacokinetics of Metoclopramide When Administered as the Orally Disintegrating Tablet Compared to Reglan® Tablets in Subjects With Diabetic Gastroparesis	N/A
Recruiting	`NCT04254549` - Rifaximin in Patients With Diabetic Gastroparesis	Phase 2
Not yet recruiting	`NCT04661215` - Pyloric Sphincter Abnormalities in Patients With Gastroparesis Symptoms

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.