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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
116
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.
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.
Chinese University of Hong Kong
Hong Kong, Hong Kong, China
Re-intervention rate
Percentage of patients requiring additional endoscopic intervention due to stent dysfunction
Time frame: 1 year
Technical success
Successful placement of the DS across the site of obstruction, as confirmed by endoscopy or flouroscopy.
Time frame: 1 day
Clinical success
Improvement of at least 1 point in the GOOS within 3 days after stent insertion
Time frame: 3 days
Adverse events rate
Graded according to the lexicon of endoscopic adverse events
Time frame: 1 year
Mortality
Death from any cause
Time frame: 30 days
Gastric outlet obstruction scores (GOOS)
Scoring system for food intake
Time frame: 1 year
Stent dysfunction
Restenosis of the stent due to tumour ingrowth or overgrowth, stent migration, or fracture
Time frame: 1 year
Duration of stent patency
calculated from the time of stent placement to the time of stent dysfunction
Time frame: 1 year
Quality of life assessment scores
EORTC QLQ-C30
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Time frame: 1 year