Partially Covered Versus Uncovered Pyloro-duodenal Stents for Unresectable Malignant Gastric Outlet Obstruction. A Double Blinded Randomised Controlled Trial.

Phase 3

Completed

• Conditions: Unresectable Malignant Gastric Outlet Obstruction
• Interventions: Other: Partially covered pyloro-duodenal stent; Other: Uncovered pyloro-duodenal stents

• Registration Number: NCT03223831
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

To compare the efficacy of a novel partially covered (PC) versus uncovered (UC) pyloro-duodenal stents (DS) in unresectable malignant gastric outlet obstruction. We hypothesize that the use of PCDS could reduce the re-intervention rates when compared to UCDS.

Detailed Description

This would be a prospective multi-centred double-blinded randomised controlled study including all patients suffering from malignant gastric outlet obstruction due unresectable primary gastro-duodenal or pancreatico-biliary malignancies. Five international institutions in Hong Kong, Singapore and India would participate in the study.

The procedure would be performed under conscious sedation or monitored anaesthesia. The patients would be randomised PCDS or UCDS after cannulation of the obstruction site is achieved with the guide-wire. The patients or assessors would be blinded to the type of stent that is inserted.

Study Timeline

• Study First Submitted: 2017-07-14
• Study First Submitted QC: 2017-07-18
• Study First Posted: 2017-07-21
• Study Start: 2017-08-01
• Status Verified: 2020-11
• Primary Completion: 2020-11-01
• Study Completion: 2020-11-01
• Last Update Submitted: 2020-11-09
• Last Update Posted: 2020-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• Consecutive patients ≥ 18 years old
• Confirmed unresectable gastro-duodenal or pancreatico-biliary malignancies
• Suffering from gastric outlet obstruction with a gastric outlet obstruction score of ≤ 1 (appendix 1) 19
• Performance status ECOG ≤3 (appendix 2)

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Exclusion Criteria

• Prior metallic stent placement
• Severe comorbidities precluding the endoscopic procedure (such as cardiopulmonary disease, sepsis, or a bleeding disorder)
• Life expectancy of less than 1 month
• History of gastric surgery
• Linitus plastica
• Coagulation disorders
• Pregnancy
• Unable to give informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Partially covered duodenal stent (PCDS)	Partially covered pyloro-duodenal stent	The PCDS used in the current study is a partially covered metallic pyloro-duodenal stent. It consists of two portions. The stent is 2cm in diameter and the proximal 2cm of the stent is uncovered and flared. The remaining of the stent is covered, where a polytetrafluoroethylene (PTFE) membrane is held between two nitinol mesh.
Uncovered duodenal stent (UDS)	Uncovered pyloro-duodenal stents	The UCDS used in the current study is an uncovered stent made of nitinol wire, with a diameter of 20mm. This stent is an unfixed-cell braided stent with low axial force, high flexibility and good conformability.

Primary Outcome Measures

Name	Time	Method
Re-intervention rate	1 year	Percentage of patients requiring additional endoscopic intervention due to stent dysfunction

Secondary Outcome Measures

Name	Time	Method
Duration of stent patency	1 year	calculated from the time of stent placement to the time of stent dysfunction
Clinical success	3 days	Improvement of at least 1 point in the GOOS within 3 days after stent insertion
Adverse events rate	1 year	Graded according to the lexicon of endoscopic adverse events
Gastric outlet obstruction scores (GOOS)	1 year	Scoring system for food intake
Stent dysfunction	1 year	Restenosis of the stent due to tumour ingrowth or overgrowth, stent migration, or fracture
Technical success	1 day	Successful placement of the DS across the site of obstruction, as confirmed by endoscopy or flouroscopy.
Quality of life assessment scores	1 year	EORTC QLQ-C30
Mortality	30 days	Death from any cause

Trial Locations

Locations (1)

Chinese University of Hong Kong; 🇨🇳 Hong Kong, Hong Kong, China