Recruiting

EUS-guided Gastroenterostomy

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT05994521

Conditions

Cancer Gi

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ERCP alone

ERCP +ProEUS-GE

Study Details

Brief summary:

The goal of this randomized controlled trial is to investigate the effectiveness and safety of Prophylactic EUS-gastroenterostomy (ProEUS-GE) as a preventative approach for malignant gastric outlet obstruction (MGOO) in men and women aged 18 years or older diagnosed with periampullary cancer.

The main question this study aims to answer is can ProEUS-GE effectively prevent the occurrence of MGOO in patients with periampullary cancer?

Patients will be randomly assigned to one of two groups: Group 1 (ERCP alone) or Group 2 (ERCP + ProEUS-GE). The study will compare the outcomes between these groups to determine the effectiveness of ProEUS-GE in preventing MGOO.

Researchers will compare Group 1 (ERCP alone) with Group 2 (ERCP + ProEUS-GE) to see if the addition of ProEUS-GE leads to a reduced occurrence of MGOO in patients with periampullary cancer.

The primary endpoint is the rate of malignant gastric outlet obstruction.

Conditions

Cancer Gi

Study ID

NCT05994521

Start date

Apr 9, 2024

Status verified date

Sep, 2024

Completion date

Aug, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria (all of the following):

1. Radiological diagnosis of a periampullary cancer that is precluded from upfront surgical resection of curative intent due to advanced tumor stage. These include locally advanced or metastatic cancers of the pancreatic head, distal bile duct, duodenum, or ampulla. cancers.
2. Elevated liver function tests requiring ERCP without evidence of MGOO of significant gastroparesis (see exclusion criterion #3 and #4)
3. ECOG 0 or 1
4. ASA<4
5. Provision of informed consent

Exclusion Criteria (any of the following):

1. Patient with clinical and radiological evidence of malignant gastric outlet obstruction defined as Gastric Outlet Obstruction Scoring System (GOOSS) of < 3 with radiological and/or endoscopic evidence of a mechanical obstruction from a gastric or duodenal stricture. GOOSS is a validated tool for assessing MGOO and is scored based on the diet tolerated by the patient: 0 for no oral intake, 1 for liquids only, 2 for soft diet, and 3 for low residue or full diet.
2. Gastroparesis with a Gastroparesis Cardinal Symptom Index (GCSI) of >2. Gastroparesis is defined as having symptoms of MGOO without radiological and/or endoscopic evidence of mechanical obstruction.
3. Uncorrectable coagulopathy and/or thrombocytopenia
4. Age < 18 or ≥ 85
5. Evidence of peritoneal carcinomatosisAscites
6. Liver metastasis > 30% of the liver volume
7. Portal hypertension with gastroesophageal varices and/or ascites
8. Surgically altered upper gastrointestinal anatomy

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: ERCP alone

ERCP procedure alone and management of MGOO will be on a wait-and-see approach, using endoscopic interventions performed only if obstruction is clinically diagnosed

experimental: ERCP + ProEUS-GE

ERCP with prophylactic eus-guided gastroenterostomy

Interventions

ERCP alone

ERCP with biliary stenting will be performed alone. ERCP is part of standard of care for biliary drainage. An endoscope is advanced to the small intestines and a metal stent is inserted through the tumor instead of bypassing the tumor to effectively drain the biliary system under x-ray guidance.

Management of MGOO will be on a wait-and-see approach, using endoscopic interventions performed only if obstruction is clinically diagnosed

ERCP +ProEUS-GE

ERCP is performed as described above. following the ERCP, the scoped is switched for an echoendoscope which is advanced to the stomach. A stent is then placed between the stomach and the small intestines, creating a connection (ProEUS-GE).

Primary outcome measure

  • Rate of gastric outlet obstruction (GOO) [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Yen-I Chen, MD

(514) 934-1934yen-i.chen@mgcill.com

Myriam Martel, MSc

myriam.martel@muhc.mcgill.ca

Locations

McGill University Health Center

Recruiting

Montréal, Canada

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Oct 1, 2024

Last verified

Sep, 2024

Keywords

  • periampullary cancer
  • ERCP
  • EUS-Guided gastroeterostomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2024-10-01.