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

Unresectable Malignant Gastric Outlet Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03223831
• Other study ID #: CRE2016.701-T
• Status: Completed
• Phase: Phase 3
• Start date: August 1, 2017
• Est. completion date: November 1, 2020

Study information

• Verified date: November 2020
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: November 1, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Outlet Obstruction
• Pyloric Stenosis
• Unresectable Malignant Gastric Outlet Obstruction

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Chinese University of Hong Kong	Hong Kong	Hong Kong

Sponsors (5)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Baldota Institute of Digestive Diseases, Mumbai, India., Changi General Hospital, National University Hospital, Singapore, Singapore General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Re-intervention rate	Percentage of patients requiring additional endoscopic intervention due to stent dysfunction	1 year
Secondary	Technical success	Successful placement of the DS across the site of obstruction, as confirmed by endoscopy or flouroscopy.	1 day
Secondary	Clinical success	Improvement of at least 1 point in the GOOS within 3 days after stent insertion	3 days
Secondary	Adverse events rate	Graded according to the lexicon of endoscopic adverse events	1 year
Secondary	Mortality	Death from any cause	30 days
Secondary	Gastric outlet obstruction scores (GOOS)	Scoring system for food intake	1 year
Secondary	Stent dysfunction	Restenosis of the stent due to tumour ingrowth or overgrowth, stent migration, or fracture	1 year
Secondary	Duration of stent patency	calculated from the time of stent placement to the time of stent dysfunction	1 year
Secondary	Quality of life assessment scores	EORTC QLQ-C30	1 year