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| Name | Class |
|---|---|
| National University Hospital, Singapore | OTHER |
| Singapore General Hospital | OTHER |
| Changi General Hospital | OTHER |
| Baldota Institute of Digestive Diseases, Mumbai, India. |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Partially covered duodenal stent (PCDS) | Active Comparator | 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. |
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| Uncovered duodenal stent (UDS) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Partially covered pyloro-duodenal stent | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Re-intervention rate | Percentage of patients requiring additional endoscopic intervention due to stent dysfunction | 1 year |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Teoh, FRCSEd(Gen | anthoyteoh@surgery.cuhk.edu.hk | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese University of Hong Kong | Hong Kong | Hong Kong | China |
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| UNKNOWN |
Recruited patients would be randomized to receive either uncovered duodenal stents or partially covered duodenal stents.
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Recruited patients would not be informed of the type of stent that was inserted
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| Uncovered pyloro-duodenal stents | Other | 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. |
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| 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 |