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

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.

Study Overview

• Status: Completed
• Conditions: Unresectable Malignant Gastric Outlet Obstruction
• Intervention / Treatment: Other: Partially covered pyloro-duodenal stent; Other: Uncovered pyloro-duodenal stents

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 Type: Interventional
• Enrollment (Actual): 116
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Hong Kong
    • Hong Kong, Hong Kong, China
      • Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Partially covered duodenal stent (PCDS); 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.	Other: Partially covered pyloro-duodenal stent; The PCDS (Niti-S COMVITM - Flare, Taewoong, Gyeonggi-do, South Korea) used in the current study is a partially covered metallic pyloro-duodenal stent. It consists of two portions (Figure 1). The stent is 2cm in diameter and the proximal 2cm of the stent is uncovered and flared. This is designed to provide anchorage of the stent to surrounding tissue and reduce the risk of migration. The remaining of the stent is covered, where a polytetrafluoroethylene (PTFE) membrane is held between two nitinol mesh to prevent the risk of tumour ingrowth into the stent. The stents come in lengths of 6, 8, 10 & 12cm.; Other Names: PCDS
ACTIVE_COMPARATOR: Uncovered duodenal stent (UDS); 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.	Other: Uncovered pyloro-duodenal stents; The UCDS (Niti-S pyloric-duodenal D stent, Taewoong, Gyeonggi-do, South Korea) used in the current study is an uncovered stent made of nitinol wire, with a diameter of 20mm and length of 6,8,10,12cm. This stent is an unfixed-cell braided stent with low axial force, high flexibility and good conformability.; Other Names: UCDS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-intervention rate	Percentage of patients requiring additional endoscopic intervention due to stent dysfunction	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: National University Hospital, Singapore; Singapore General Hospital; Changi General Hospital; Baldota Institute of Digestive Diseases, Mumbai, India.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2017
• Primary Completion (ACTUAL): November 1, 2020
• Study Completion (ACTUAL): November 1, 2020

Study Registration Dates

• First Submitted: July 14, 2017
• First Submitted That Met QC Criteria: July 18, 2017
• First Posted (ACTUAL): July 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 10, 2020
• Last Update Submitted That Met QC Criteria: November 9, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: unresectable malignant gastric outlet obstruction; Partially covered pyloro-duodenal stents; uncovered pyloro-duodenal stents
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Pyloric Stenosis; Gastric Outlet Obstruction
• Other Study ID Numbers: CRE2016.701-T

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No