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

The Chinese University of Hong Kong

Status and phase: Completed; Phase 3

Conditions: Unresectable Malignant Gastric Outlet Obstruction

Treatments: Other: Uncovered pyloro-duodenal stents; Other: Partially covered pyloro-duodenal stent

Study type: Interventional

Funder types: Other

Identifiers

NCT03223831

CRE2016.701-T

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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116 participants in 2 patient groups

Partially covered duodenal stent (PCDS)

Active Comparator group

Description:

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.

Treatment:

Other: Partially covered pyloro-duodenal stent

Uncovered duodenal stent (UDS)

Active Comparator group

Description:

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.

Treatment:

Other: Uncovered pyloro-duodenal stents