Novel Balloon-Assisted vs Direct Technique in EUS-Guided Gastroenterostomy

Not Applicable

Not yet recruiting

• Conditions: Gastric Outlet Obstruction

• Registration Number: NCT07161856
• Lead Sponsor: Changhai Hospital

Brief Summary

Gastric outlet obstruction (GOO) refers to mechanical blockage at the pylorus or duodenum, most commonly caused by unresectable malignancies of the stomach, duodenum, or pancreas. At the time of diagnosis, the majority of lesions are no longer amenable to curative resection, and median survival ranges from only 11.3 to 21.3 weeks. Throughout the disease course, patients develop nausea, vomiting, and severe malnutrition, which markedly impair quality of life. Current strategies to relieve obstruction include endoscopic stent placement and surgical gastrojejunostomy; however, each is associated with distinct drawbacks, such as stent occlusion, prolonged operative times, and high complication rates.

Endoscopic ultrasound-guided gastroenterostomy (EUS-GE) is a minimally invasive technique in which a gastric-jejunal anastomosis is created under real-time EUS guidance, bypassing the obstructed segment and establishing a gastrojejunal shortcut. Compared with conventional surgery or endoscopic luminal stenting, EUS-GE offers reduced procedural trauma and lower recurrence rates, providing GOO patients with an additional, less-invasive therapeutic option.

Three main EUS-GE approaches have been described: the direct method, the balloon-assisted method, and the double-balloon-assisted method. The direct method requires large volumes of water instillation, posing hemodynamic risks in patients with cardiovascular or cerebrovascular disease. The double-balloon technique relies on expensive, specialized devices that have not yet been widely adopted. The conventional balloon-assisted method demands needle puncture of a partially inflated balloon, which compromises stability and can displace the target jejunum away from the gastric wall. All three techniques are technically demanding, limiting their broad clinical dissemination.

The investigators therefore designed and previously reported a dedicated single-balloon-assisted device specifically for EUS-GE. This novel system aims to shorten procedure time, reduce intraprocedural water volume, and enhance procedural safety. The present prospective, multicenter, randomized controlled trial was undertaken to validate the clinical efficacy and safety of this new single-balloon-assisted technique compared with the conventional direct water-injection method.

Detailed Description

This multicenter, single-blind, RCT is designed to enroll 272 patients across five high-volume tertiary referral centers in China. The study is planned to commence in July 2025 and continue until the final patient completed 12 months of follow-up or passed away. The primary outcome is the operation duration. Secondary outcomes are technical success rate, clinical success rate, intraoperative water injection volume, quality of life assessment, length of hospital stay, and incidence of adverse events (AEs).

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-14
• Study Start: 2025-09-01
• Study First Submitted QC: 2025-09-08
• Last Update Submitted: 2025-09-08
• Study First Posted: 2025-09-09
• Last Update Posted: 2025-09-09
• Primary Completion: 2026-08-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 272

Inclusion Criteria

• Age ranges from 18 to 80 years old
• GOO patients caused by all reasons (including benign diseases such as ulcers or malignant tumors)
• Not suitable for or cannot tolerate surgical operations and endoscopic intestinal stent implantation
• There are no absolute contraindications for EUS-GE
• Signed informed consents

Exclusion Criteria

• Pregnant and lactating women
• Unable or refused to provide informed consents
• Patients with cognitive impairment, aphasia, mental disorders, or other conditions that may affect the patient's cooperation
• Patients with endoscopic contraindications, anesthesia contraindications, digestive tract perforation or abdominal cavity infection
• The tumor invades the duodenum or the upper segment of the jejunum Individuals whom the investigator deems unsuitable for participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
operation duration	Perioperative	the duration from the moment the surgical instrument enters the body and begins operation until the completion of the gastrojejunostomy and placement of the intraluminal stent

Secondary Outcome Measures

Name	Time	Method
technical success	Perioperative	successfully pass through the narrow intestinal segment and implant the stent, that is, the LAMS stent fully expands and is confirmed through a combination of endoscopy, ultrasound and fluorescence microscopy