Partially Covered Versus Uncovered Pyloro-duodenal Stents for Unresectable Malignant Gastric Outlet Obstruction. A Double Blinded Randomised Controlled Trial.
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|ClinicalTrials.gov Identifier: NCT03223831|
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : November 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Unresectable Malignant Gastric Outlet Obstruction||Other: Partially covered pyloro-duodenal stent Other: Uncovered pyloro-duodenal stents||Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||116 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Recruited patients would be randomized to receive either uncovered duodenal stents or partially covered duodenal stents.|
|Masking Description:||Recruited patients would not be informed of the type of stent that was inserted|
|Official Title:||Partially Covered Versus Uncovered Pyloro-duodenal Stents for Unresectable Malignant Gastric Outlet Obstruction. A Double Blinded Randomised Controlled Trial.|
|Actual Study Start Date :||August 1, 2017|
|Estimated Primary Completion Date :||August 1, 2019|
|Estimated Study Completion Date :||August 1, 2019|
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 Name: 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 Name: UCDS
- Re-intervention rate [ Time Frame: 1 year ]Percentage of patients requiring additional endoscopic intervention due to stent dysfunction
- Technical success [ Time Frame: 1 day ]Successful placement of the DS across the site of obstruction, as confirmed by endoscopy or flouroscopy.
- Clinical success [ Time Frame: 3 days ]Improvement of at least 1 point in the GOOS within 3 days after stent insertion
- Adverse events rate [ Time Frame: 1 year ]Graded according to the lexicon of endoscopic adverse events
- Mortality [ Time Frame: 30 days ]Death from any cause
- Gastric outlet obstruction scores (GOOS) [ Time Frame: 1 year ]Scoring system for food intake
- Stent dysfunction [ Time Frame: 1 year ]Restenosis of the stent due to tumour ingrowth or overgrowth, stent migration, or fracture
- Duration of stent patency [ Time Frame: 1 year ]calculated from the time of stent placement to the time of stent dysfunction
- Quality of life assessment scores [ Time Frame: 1 year ]EORTC QLQ-C30
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03223831
|Contact: Anthony Teoh, FRCSEd(Genemail@example.com|
|China, Hong Kong|
|Chinese University of Hong Kong||Recruiting|
|Hong Kong, Hong Kong, China|
|Contact: Anthony Y Teoh, FRCSEd(Gen) 26322956 firstname.lastname@example.org|
|Principal Investigator: Anthony Y Teoh, FRCSEd(Gen)|
|Principal Investigator:||Anthony Teoh, FRCSEd(Genemail@example.com|