Comparison of Outcomes for Single vs Double Pyloromyotomy for Gastroparesis Randomized Controlled Trial

Launched by UNIVERSITY OF ARKANSAS · Dec 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of two different surgical techniques for treating severe gastroparesis, a condition where the stomach takes too long to empty its contents, causing symptoms like nausea, vomiting, and bloating. Patients referred to the University of Arkansas Medical Sciences (UAMS) for a specific procedure called gastric peroral endoscopic pyloromyotomy (G-POEM) will be randomly assigned to receive either a single or double pyloromyotomy. The goal is to determine which method leads to better clinical outcomes for patients suffering from this challenging condition.

To be eligible for the trial, participants must be at least 18 years old and have severe gastroparesis that has not improved despite medical treatment for more than six months. Patients who have undergone previous gastric surgery or have certain other medical conditions will not be included. Those who join the study can expect to undergo the G-POEM procedure and will be monitored for their symptoms and recovery afterward. This trial aims to provide valuable insights that could help improve treatment options for future patients with gastroparesis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with refractory (persistent symptoms for \>6 months refractory to medical therapy) and severe gastroparesis based on GCSI \> 2, with confirmed im-paired gastric emptying based on gastric emptying.
• • Persons 18 years or older at the time of signing the informed consent
• Exclusion Criteria:
• • No previous attempt with at least one prokinetic drug.
• • Previous gastric surgery.
• • Esophageal or gastric varices and /or portal gastropathy.
• • Pregnant patients.
• • Malignant or pre-malignant gastric diseases.