EUS-GE vs ES for Palliation of Gastric Outlet Obstruction

Status Recruiting

Clinical Trial Summary

Gastric outlet obstruction (GOO) is a common complication of luminal malignancies which is associated with substantial morbidity. Palliation of GOO has traditionally been through the surgical bypass of the obstructed lumen by creating an opening between the stomach and small intestine. However, In recent years, a less invasive approach, i.e. endoscopic stenting, has gained wide acceptance to treat unresectable malignant gastric outlet obstruction. In this study, the investigators are going to compare the safety and efficacy of the two different endoscopic techniques including Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) and enteral stenting (ES).

Clinical Trial Description

In recent years, Enteral Stenting (ES) has commonly been used as the first line management of unresectable malignant gastric outlet obstruction. On the other hand, Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) is the most recently described technique for palliation of malignant GOO, which has the theoretical potential to minimize the risk for stent occlusion while maintaining the less invasive endoscopic approach. This novel endoscopic treatment entails creating a gastroenterostomy under EUS-guidance thereby bypassing the occluded lumen. This endoscopic technique has been performed to treat patients with GOO since 2014, and recent retrospective studies have shown that EUS-GE was comparable to ES in terms of efficacy and safety; however, EUS-GE was associated with a significantly decreased risk of recurrent GOO and reinterventions. Based on the investigator's clinical experience for the last three years and the above-mentioned study results, the goal of this study is to prospectively compare EUS-GE with ES in the management of unresectable malignant gastric outlet obstruction. The investigators hypothesize that EUS-GE is associated with comparable technical and clinical success and safety profile while requiring fewer re-interventions. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03259763
Study type	Interventional
Source	Johns Hopkins University
Contact	Mouen A. Khashab, MD
Phone	443-509-3388
Email	mkhasha1@jhmi.edu
Status	Recruiting
Phase	N/A
Start date	October 26, 2020
Completion date	December 2024

View Details

See also
Status	Clinical Trial	Phase
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Recruiting	`NCT05561907` - Enteral Anastomosis for the Treatment of Gastric Outlet Obstruction: A Randomized Controlled Study Comparing Endoscopic Versus Surgical Gastrojejunostomy	N/A
Not yet recruiting	`NCT05605327` - EUS-guided Versus Laparoscopic Gastrojejunostomy for Malignant Gastric Outlet Obstruction	N/A
Completed	`NCT02299258` - Gastric Outlet Obstructions Tailored Covered Stents for GOO	N/A
Not yet recruiting	`NCT06174805` - AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction IDE	N/A
Recruiting	`NCT05640947` - Endoscopic Ultrasound-guided Large Diameter Lumen-apposing Metal Stent Gastro-gastrostomy for Bypass Reversal in Patients With Roux-en-y Gastric Bypass	N/A
Terminated	`NCT00487552` - Magnetic Anastomosis Device Relief of Malignant Gastric Outlet Obstruction	Phase 1
Completed	`NCT00556283` - RCT: STARR vs Biofeedback	Phase 4
Enrolling by invitation	`NCT05041608` - Endoscopic Surgery for Gastrointestinal Disorders: A Multicenter Registry Study
Completed	`NCT03823690` - EPASS Versus Uncovered Duodenal Stent for Unresectable Malignant Gastric Outlet Obstruction.	N/A
Recruiting	`NCT05644951` - Clinical Trial of EPASS With Hot AXIOS System	N/A
Completed	`NCT00991614` - EVOLUTION® Duodenal Stent for Duodenal or Gastric Outlet Obstruction Caused by Malignant Neoplasms	N/A
Recruiting	`NCT04813055` - Prospective Registry Of Therapeutic EndoscopiC ulTrasound
Completed	`NCT03223480` - EUS - Guided Balloon-occluded Gastrojejunostomy Bypass	Phase 2/Phase 3
Completed	`NCT04660695` - Nasobiliary Drain Assisted EUS-guided Gastroenterostomies in Unresectable Malignant Gastric Outlet Obstruction
Completed	`NCT01839292` - ComVi and D-type Stent in Malignant GOO	N/A
Recruiting	`NCT06071507` - Management of Malignant Gastric Outlet Obstruction Between Surgery and Endoscopy

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.