Unresectable Malignant Gastric Outlet Obstruction
Conditions
Keywords
unresectable malignant gastric outlet obstruction, Partially covered pyloro-duodenal stents, uncovered pyloro-duodenal stents
Brief summary
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
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.
Interventions
OTHERPartially 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.
OTHERUncovered 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.
Sponsors
National University Hospital, Singapore
Singapore General Hospital
Changi General Hospital
Baldota Institute of Digestive Diseases, Mumbai, India.
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Recruited patients would not be informed of the type of stent that was inserted
Intervention model description
Recruited patients would be randomized to receive either uncovered duodenal stents or partially covered duodenal stents.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Re-intervention rate | 1 year | Percentage of patients requiring additional endoscopic intervention due to stent dysfunction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical success | 3 days | Improvement of at least 1 point in the GOOS within 3 days after stent insertion |
| Adverse events rate | 1 year | Graded according to the lexicon of endoscopic adverse events |
| Mortality | 30 days | Death from any cause |
| Technical success | 1 day | Successful placement of the DS across the site of obstruction, as confirmed by endoscopy or flouroscopy. |
| Stent dysfunction | 1 year | Restenosis of the stent due to tumour ingrowth or overgrowth, stent migration, or fracture |
| Duration of stent patency | 1 year | calculated from the time of stent placement to the time of stent dysfunction |
| Quality of life assessment scores | 1 year | EORTC QLQ-C30 |
| Gastric outlet obstruction scores (GOOS) | 1 year | Scoring system for food intake |
Countries
China
Outcome results
None listed