NCT03823690

EPASS Versus Uncovered Duodenal Stent for Unresectable Malignant Gastric Outlet Obstruction.

Completed NA Last updated 31 August 2023

What this trial tests

NA trial testing EUS-guided gastrojejunstomy in Gastric Outlet Obstruction in 97 participants. Completed in 30 May 2022.

Timeline

1 February 2020

Primary endpoint
30 May 2022

30 May 2022

Quick facts

Lead sponsor	Chinese University of Hong Kong
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	97
Start date	1 February 2020
Primary completion	30 May 2022
Estimated completion	30 May 2022
Sites	1 location across Hong Kong

Drugs / interventions tested

• EUS-guided gastrojejunstomy
• The pyloro-duodenal stent

Conditions studied

• Gastric Outlet Obstruction — all drugs for Gastric Outlet Obstruction →

Sponsor

Chinese University of Hong Kong

Who can join

18 and older, any sex, with Gastric Outlet Obstruction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Surgical gastrojejunostomy is the conventional treatment for palliating patients suffering from of inoperable malignant gastric outlet obstruction (GOO). Although, the procedure is associated with a high success and low re-intervention rates, there is a risk of morbidities (10% - 16%) and mortalities (7%). The placement of a pyloro-duodenal self-expandable metallic stent (SEMS) is an alternative to surgery for the palliating these patients. As compared to surgery, the procedure is associated with shorter hospital stay, reduced morbidities and cost. However, the clinical efficacy of SEMS is limited by several problems. In uncovered SEMS, the long-term patency is reduced by tumor ingrowth leading to subsequent re-stenosis. In covered SEMS, stent migration occurs at a frequency of 14-25% and it is a major obstacle to stent patency. As a result, randomized trials comparing uncovered stents and partially or fully covered stents in patients with malignant GOO have reported comparable stent patency between the two types of stents.

Recently, the creation of a gastrojejunostomy under EUS (EUS-GJ) guidance using lumen-apposing stents has been described. The procedure was associated with a technical success rate of around 90% and clinical success of 85% to 100%. The procedure holds the potential to create a gastrojejunostomy without surgery. Furthermore, there is a low risk of tumor ingrowth and stent migration, thus improving the stent patency and reducing the need of re-intervention. We have previously published a novel method of creating EUS-GJ with the use of a double balloon occluder (EPASS). The device provides a stable condition for performance of EUS-GJ and improves the safety of the procedure. However, there is limited data on how EPASS compares to endoscopic stenting. The aim of the current study is thus to compare EPASS and DS under a randomized setting.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Endoscopic ultrasonography-guided gastroenterostomy versus uncovered duodenal metal stenting for unresectable malignant gastric outlet obstruction (DRA-GOO): a multicentre randomised controlled trial.
   Teoh AYB, Lakhtakia S, Tarantino I, Perez-Miranda M, et al · · 2025 · cited 38× · PMID 40347959 · DOI 10.1016/s2468-1253(25)00136-0
2. Endoscopic ultrasonography-guided gastroenterostomy versus uncovered duodenal metal stenting for unresectable malignant gastric outlet obstruction (DRA-GOO): a multicentre randomised controlled trial.
   Teoh AYB, Lakhtakia S, Tarantino I, Perez-Miranda M, et al · · 2024 · cited 19× · PMID 38061378 · DOI 10.1016/s2468-1253(23)00242-x
3. Endoscopic ultrasound-guided gastroenterostomy versus duodenal stenting for gastric outlet obstruction: A systematic review, meta-analysis, and meta-regression.
   Jain H, Dey D, Odat RM, Hussein AM, et al · · 2024 · cited 5× · PMID 39465748 · DOI 10.1097/md.0000000000039948
4. Endoscopic ultrasonography-guided gastroenterostomy versus surgical gastrojejunostomy for palliation of malignant gastric outlet obstruction (ENDURO): study protocol for a randomized controlled trial.
   Kastelijn JB, van de Pavert YL, Besselink MG, Fockens P, et al · · 2023 · cited 5× · PMID 37749590 · DOI 10.1186/s13063-023-07522-7