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Completed

NCT Number: NCT03223831

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

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.

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Key information

Conditions

Unresectable Malignant Gastric Outlet Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chinese University of Hong Kong

Hong Kong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: PCDS

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.

Other names: UCDS

Primary outcomes

  1. Re-intervention rate

    Time frame: 1 year

    Percentage of patients requiring additional endoscopic intervention due to stent dysfunction

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Baldota Institute of Digestive Diseases, Mumbai, India.
  • Changi General Hospital
  • National University Hospital, Singapore
  • Singapore General Hospital

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 21, 2017
Registry last updated
Nov 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.