NCT03823690

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
1 year until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

2.3 years

First QC Date

January 24, 2019

Last Update Submit

August 30, 2023

Conditions

Gastric Outlet Obstruction

Outcome Measures

Primary Outcomes (1)

  • Re-intervention rate

    The percentage of patients requiring additional endoscopic intervention due to stent dysfunction.

    6 months

Secondary Outcomes (9)

  • Technical success rate

    1 day

  • Clinical success rate

    3 days

  • Stent dysfunction rate

    6 months

  • Duration of stent patency

    6 months

  • Adverse events rate

    6 months

  • +4 more secondary outcomes

Study Arms (2)

EUS-guided gastrojejunostomy

ACTIVE COMPARATOR

The procedures would be performed under conscious sedation or monitored anesthesia by a therapeutic gastroscope. The endoscope would be used to reach the site of obstruction. The stricture would be cannulated with a 0.025" or 0.035" guide-wire. The double balloon occluder would then be inserted on guidewire beyond the duodenal-jejunal flexure and the two balloons of the occluder would be inflated. A segment of duodenum/jejunum would then be occluded and saline would be injected. A linear echoendoscope would then be inserted into the stomach to guide insertion of the gastrojejunostomy stent.

Device: EUS-guided gastrojejunstomy

Pyloro-duodenal stent

ACTIVE COMPARATOR

The uncovered DS used in this study is Wallflex (Boston, Natick, MA, USA), made of nitinol wire, with a diameter of 22mm and length of 6, 9, 12cm. This stent is a braided stent with high axial force, good flexibility and conformability.

Device: The pyloro-duodenal stent

Interventions

EUS-guided gastrojejunstomyDEVICE

As listed in the arms description

Also known as: EPASS
EUS-guided gastrojejunostomy
The pyloro-duodenal stentDEVICE

As listed in the arms description

Also known as: DS
Pyloro-duodenal stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consecutive patients ≥ 18 years old
  • Confirmed unresectable distal gastric or duodenal or pancreatico-biliary malignancies
  • Suffering from gastric outlet obstruction with a gastric outlet obstruction score of ≤ 1
  • Performance status ECOG ≤3

You may not qualify if:

  • 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 plastic
  • Multiple-level bowel obstruction confirmed on radiographic studies such as small bowel series or abdominal computed tomography
  • Coagulation disorders
  • Pregnancy
  • Unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Related Publications (2)

  • Teoh AYB, Lakhtakia S, Tarantino I, Perez-Miranda M, Kunda R, Maluf-Filho F, Dhir V, Basha J, Chan SM, Ligresti D, Ma MTW, de la Serna-Higuera C, Yip HC, Ng EKW, Chiu PWY, Itoi T. Endoscopic ultrasonography-guided gastroenterostomy versus uncovered duodenal metal stenting for unresectable malignant gastric outlet obstruction (DRA-GOO): a multicentre randomised controlled trial. Lancet Gastroenterol Hepatol. 2025 Jun;10(6):e8-e16. doi: 10.1016/S2468-1253(25)00136-0.

    PMID: 40347959DERIVED

  • Teoh AYB, Lakhtakia S, Tarantino I, Perez-Miranda M, Kunda R, Maluf-Filho F, Dhir V, Basha J, Chan SM, Ligresti D, Ma MTW, de la Serna-Higuera C, Yip HC, Ng EKW, Chiu PWY, Itoi T. Endoscopic ultrasonography-guided gastroenterostomy versus uncovered duodenal metal stenting for unresectable malignant gastric outlet obstruction (DRA-GOO): a multicentre randomised controlled trial. Lancet Gastroenterol Hepatol. 2024 Feb;9(2):124-132. doi: 10.1016/S2468-1253(23)00242-X. Epub 2023 Dec 4.

    PMID: 38061378DERIVED

MeSH Terms

Conditions

Gastric Outlet Obstruction

Condition Hierarchy (Ancestors)

Stomach DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Recruited patients would not be informed of the type of treatment that was received.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The patients would be randomized to either EUS-guided balloon-occluded gastrojejunostomy bypass (EPASS) or uncovered duodenal stent after cannulation of the obstruction site is achieved with the guide-wire.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Honorary Associate Professor

Study Record Dates

First Submitted

January 24, 2019

First Posted

January 30, 2019

Study Start

February 1, 2020

Primary Completion

May 30, 2022

Study Completion

May 30, 2022

Last Updated

August 31, 2023

Record last verified: 2023-08

Locations

HK(1)