Back to resultsPartially Covered Versus Uncovered Pyloro-duodenal Stents for Unresectable Malignant Gastric Outlet Obstruction. A Double Blinded Randomised Controlled Trial.
Primary Purpose
Unresectable Malignant Gastric Outlet Obstruction
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Partially covered pyloro-duodenal stent
Uncovered pyloro-duodenal stents
Sponsored by
About this trial
This is an interventional treatment trial for Unresectable Malignant Gastric Outlet Obstruction focused on measuring unresectable malignant gastric outlet obstruction, Partially covered pyloro-duodenal stents, uncovered pyloro-duodenal stents
Eligibility Criteria
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
Sites / Locations
- Chinese University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Partially covered duodenal stent (PCDS)
Uncovered duodenal stent (UDS)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Re-intervention rate
Percentage of patients requiring additional endoscopic intervention due to stent dysfunction
Secondary Outcome Measures
Technical success
Successful placement of the DS across the site of obstruction, as confirmed by endoscopy or flouroscopy.
Clinical success
Improvement of at least 1 point in the GOOS within 3 days after stent insertion
Adverse events rate
Graded according to the lexicon of endoscopic adverse events
Mortality
Death from any cause
Gastric outlet obstruction scores (GOOS)
Scoring system for food intake
Stent dysfunction
Restenosis of the stent due to tumour ingrowth or overgrowth, stent migration, or fracture
Duration of stent patency
calculated from the time of stent placement to the time of stent dysfunction
Quality of life assessment scores
EORTC QLQ-C30
Full Information
NCT ID
NCT03223831
First Posted
July 14, 2017
Last Updated
November 9, 2020
Sponsor
Chinese University of Hong Kong
Collaborators
National University Hospital, Singapore, Singapore General Hospital, Changi General Hospital, Baldota Institute of Digestive Diseases, Mumbai, India.
1. Study Identification
Unique Protocol Identification Number
NCT03223831
Brief Title
Partially Covered Versus Uncovered Pyloro-duodenal Stents for Unresectable Malignant Gastric Outlet Obstruction. A Double Blinded Randomised Controlled Trial.
Official Title
Partially Covered Versus Uncovered Pyloro-duodenal Stents for Unresectable Malignant Gastric Outlet Obstruction. A Double Blinded Randomised Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
November 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
National University Hospital, Singapore, Singapore General Hospital, Changi General Hospital, Baldota Institute of Digestive Diseases, Mumbai, India.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unresectable Malignant Gastric Outlet Obstruction
Keywords
unresectable malignant gastric outlet obstruction, Partially covered pyloro-duodenal stents, uncovered pyloro-duodenal stents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Recruited patients would be randomized to receive either uncovered duodenal stents or partially covered duodenal stents.
Masking
Participant
Masking Description
Recruited patients would not be informed of the type of stent that was inserted
Allocation
Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Partially covered duodenal stent (PCDS)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Uncovered duodenal stent (UDS)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Partially covered pyloro-duodenal stent
Other Intervention Name(s)
PCDS
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Uncovered pyloro-duodenal stents
Other Intervention Name(s)
UCDS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Re-intervention rate
Description
Percentage of patients requiring additional endoscopic intervention due to stent dysfunction
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Technical success
Description
Successful placement of the DS across the site of obstruction, as confirmed by endoscopy or flouroscopy.
Time Frame
1 day
Title
Clinical success
Description
Improvement of at least 1 point in the GOOS within 3 days after stent insertion
Time Frame
3 days
Title
Adverse events rate
Description
Graded according to the lexicon of endoscopic adverse events
Time Frame
1 year
Title
Mortality
Description
Death from any cause
Time Frame
30 days
Title
Gastric outlet obstruction scores (GOOS)
Description
Scoring system for food intake
Time Frame
1 year
Title
Stent dysfunction
Description
Restenosis of the stent due to tumour ingrowth or overgrowth, stent migration, or fracture
Time Frame
1 year
Title
Duration of stent patency
Description
calculated from the time of stent placement to the time of stent dysfunction
Time Frame
1 year
Title
Quality of life assessment scores
Description
EORTC QLQ-C30
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Teoh, FRCSEd(Gen
Organizational Affiliation
anthoyteoh@surgery.cuhk.edu.hk
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese University of Hong Kong
City
Hong Kong
State/Province
Hong Kong
Country
China
12. IPD Sharing Statement
Learn more about this trial
Partially Covered Versus Uncovered Pyloro-duodenal Stents for Unresectable Malignant Gastric Outlet Obstruction. A Double Blinded Randomised Controlled Trial.
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