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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Unresectable Malignant Gastric Outlet Obstruction

Intervention / Treatment
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* Other: Partially covered pyloro-duodenal stent
* Other: Uncovered pyloro-duodenal stents


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Recruited patients would be randomized to receive either uncovered duodenal stents or partially covered duodenal stents.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Partially covered duodenal stent (PCDS)<br>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<br>* 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.<br>* Other names: PCDS;|
| Active Comparator: Uncovered duodenal stent (UDS)<br>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<br>* 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.<br>* Other names: UCDS;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unresectable malignant gastric outlet obstruction, Partially covered pyloro-duodenal stents, uncovered pyloro-duodenal stents