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Partially Covered Versus Uncovered Pyloro-duodenal Stents for Unresectable Malignant Gastric Outlet Obstruction. A Double Blinded Randomised Controlled Trial.

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ClinicalTrials.gov Identifier: NCT03223831
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : November 15, 2018
Sponsor:
Collaborators:
National University Hospital, Singapore
Singapore General Hospital
Changi General Hospital
Baldota Institute of Digestive Diseases, Mumbai, India.
Information provided by (Responsible Party):
Anthony Teoh, Chinese University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Unresectable Malignant Gastric Outlet Obstruction Other: Partially covered pyloro-duodenal stent Other: Uncovered pyloro-duodenal stents Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Recruited patients would be randomized to receive either uncovered duodenal stents or partially covered duodenal stents.
Masking: Single (Participant)
Masking Description: Recruited patients would not be informed of the type of stent that was inserted
Primary Purpose: Treatment
Official Title: Partially Covered Versus Uncovered Pyloro-duodenal Stents for Unresectable Malignant Gastric Outlet Obstruction. A Double Blinded Randomised Controlled Trial.
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2019

Arm Intervention/treatment
Active Comparator: Partially covered duodenal stent (PCDS)
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.
Other: Partially 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.
Other Name: PCDS

Active Comparator: Uncovered duodenal stent (UDS)
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.
Other: Uncovered 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.
Other Name: UCDS




Primary Outcome Measures :
  1. Re-intervention rate [ Time Frame: 1 year ]
    Percentage of patients requiring additional endoscopic intervention due to stent dysfunction


Secondary Outcome Measures :
  1. Technical success [ Time Frame: 1 day ]
    Successful placement of the DS across the site of obstruction, as confirmed by endoscopy or flouroscopy.

  2. Clinical success [ Time Frame: 3 days ]
    Improvement of at least 1 point in the GOOS within 3 days after stent insertion

  3. Adverse events rate [ Time Frame: 1 year ]
    Graded according to the lexicon of endoscopic adverse events

  4. Mortality [ Time Frame: 30 days ]
    Death from any cause

  5. Gastric outlet obstruction scores (GOOS) [ Time Frame: 1 year ]
    Scoring system for food intake

  6. Stent dysfunction [ Time Frame: 1 year ]
    Restenosis of the stent due to tumour ingrowth or overgrowth, stent migration, or fracture

  7. Duration of stent patency [ Time Frame: 1 year ]
    calculated from the time of stent placement to the time of stent dysfunction

  8. Quality of life assessment scores [ Time Frame: 1 year ]
    EORTC QLQ-C30



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03223831


Contacts
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Contact: Anthony Teoh, FRCSEd(Gen 35052956 anthoyteoh@surgery.cuhk.edu.hk

Locations
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China, Hong Kong
Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong, China
Contact: Anthony Y Teoh, FRCSEd(Gen)    26322956    anthonyteoh@surgery.cuhk.edu.hk   
Principal Investigator: Anthony Y Teoh, FRCSEd(Gen)         
Sponsors and Collaborators
Chinese University of Hong Kong
National University Hospital, Singapore
Singapore General Hospital
Changi General Hospital
Baldota Institute of Digestive Diseases, Mumbai, India.
Investigators
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Principal Investigator: Anthony Teoh, FRCSEd(Gen anthoyteoh@surgery.cuhk.edu.hk

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Responsible Party: Anthony Teoh, Honorary Associate Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03223831     History of Changes
Other Study ID Numbers: CRE2016.701-T
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anthony Teoh, Chinese University of Hong Kong:
unresectable malignant gastric outlet obstruction
Partially covered pyloro-duodenal stents
uncovered pyloro-duodenal stents

Additional relevant MeSH terms:
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Gastric Outlet Obstruction
Pyloric Stenosis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases