Unresectable Malignant Gastric Outlet ObstructionPhase 3NCT03223831
Partially Covered Versus Uncovered Pyloro-duodenal Stents for Unresectable Malignant Gastric Outlet Obstruction. A Double Blinded Randomised Controlled Trial.
A Phase 3 study testing Partially covered pyloro-duodenal stent and Uncovered pyloro-duodenal stents in people with Unresectable Malignant Gastric Outlet Obstruction, run by Chinese University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Malignant Gastric Outlet Obstruction
- What is being tested?
- Partially covered pyloro-duodenal stent and Uncovered pyloro-duodenal stents
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to 1 Nov 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Partially covered pyloro-duodenal stent, Uncovered pyloro-duodenal stents
- Keywords
- unresectable malignant gastric outlet obstruction, Partially covered pyloro-duodenal stents, uncovered pyloro-duodenal stents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partially covered pyloro-duodenal stentOther
Also called PCDS
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.
Uncovered pyloro-duodenal stentsOther
Also called UCDS
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Partially covered pyloro-duodenal stent |
| 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. Receives: Other: Uncovered pyloro-duodenal stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-intervention rate
Percentage of patients requiring additional endoscopic intervention due to stent dysfunction
Measured: 1 year
Secondary outcomes (8)
Technical success
Successful placement of the DS across the site of obstruction, as confirmed by endoscopy or flouroscopy.
Measured: 1 day
Clinical success
Improvement of at least 1 point in the GOOS within 3 days after stent insertion
Measured: 3 days
Adverse events rate
Graded according to the lexicon of endoscopic adverse events
Measured: 1 year
Mortality
Death from any cause
Measured: 30 days
Gastric outlet obstruction scores (GOOS)
Scoring system for food intake
Measured: 1 year
Stent dysfunction
Restenosis of the stent due to tumour ingrowth or overgrowth, stent migration, or fracture
Measured: 1 year
Duration of stent patency
calculated from the time of stent placement to the time of stent dysfunction
Measured: 1 year
Quality of life assessment scores
EORTC QLQ-C30
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start1 Aug 2017
- Primary completion1 Nov 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Malignant Gastric Outlet ObstructionStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Recruited patients would be randomized to receive either uncovered duodenal stents or partially covered duodenal stents.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- National University Hospital, Singapore, Singapore General Hospital, Changi General Hospital, Baldota Institute of Digestive Diseases, Mumbai, India.
- Responsible party
- Principal investigator, Anthony Teoh, Chinese University of Hong Kong
- Investigators
- Anthony Teoh, FRCSEd(Gen, Principal investigator, anthoyteoh@surgery.cuhk.edu.hk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223831
- Sponsor's protocol ID
- CRE2016.701-T
- Status last verified
- Nov 2020
- First submitted
- 14 Jul 2017
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partially Covered Versus Uncovered Pyloro-duodenal Stents for Unresectable Malignant Gastric Outlet Obstruction. A Double Blinded Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT03223831
- Acronym / sponsor ID
- CRE2016.701-T
- Keywords
- unresectable malignant gastric outlet obstruction, Partially covered pyloro-duodenal stents, uncovered pyloro-duodenal stents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- National University Hospital, Singapore, Singapore General Hospital, Changi General Hospital, Baldota Institute of Digestive Diseases, Mumbai, India.
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Recruited patients would be randomized to receive either uncovered duodenal stents or partially covered duodenal stents.
| Arm | Type | Receives |
|---|---|---|
| Partially covered duodenal stent (PCDS) | Active comparator | Other: Partially covered pyloro-duodenal stentThe 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. |
| Uncovered duodenal stent (UDS) | Active comparator | Other: Uncovered pyloro-duodenal stentsThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partially covered pyloro-duodenal stentAlso: PCDSThe 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 | Partially covered duodenal stent (PCDS) |
| Uncovered pyloro-duodenal stentsAlso: UCDSThe 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 | Uncovered duodenal stent (UDS) |
Primary outcome
Re-intervention rate
Time frame: 1 year
Percentage of patients requiring additional endoscopic intervention due to stent dysfunction
8 secondary outcomes
Technical success
Time frame: 1 day
Clinical success
Time frame: 3 days
Adverse events rate
Time frame: 1 year
Mortality
Time frame: 30 days
Gastric outlet obstruction scores (GOOS)
Time frame: 1 year
Stent dysfunction
Time frame: 1 year
Duration of stent patency
Time frame: 1 year
Quality of life assessment scores
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Teoh, FRCSEd(Gen principal investigator
anthoyteoh@surgery.cuhk.edu.hk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Partially covered pyloro-duodenal stent and Uncovered pyloro-duodenal stents in people with Unresectable Malignant Gastric Outlet Obstruction, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-intervention rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.