Prophylactic EUS-guided Gastroenterostomy in Advanced Periampullary Cancers

NCT05994521 | Recruiting DMC

• 1 other identifier: MP-37-2024-9711
• Study Type: interventional
• Target: 110
• Locations: 3 countries
• Sites: 5

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

Keywords

periampullary cancer; ERCP; EUS-Guided gastroeterostomy

Outcome Measures

Primary Outcomes (1)

• Rate of gastric outlet obstruction (GOO)

  Gastric outlet obstruction is defined as GOOSS of \< 2 AND radiological and/or endoscopic confirmation of the presence of GOO either from a gastroduodenal stricture, stent obstruction, or stent migration.

  18 months

Secondary Outcomes (3)

• Rate of adverse events

  18 months

• Quality of life of the participant

  18 months

• Nutritional status

  18 months

Study Arms (2)

ERCP alone

ACTIVE COMPARATOR

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

Procedure: ERCP alone

ERCP + ProEUS-GE

EXPERIMENTAL

ERCP with prophylactic eus-guided gastroenterostomy

Procedure: ERCP +ProEUS-GE

Interventions

ERCP alone PROCEDURE

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 alone

ERCP +ProEUS-GE PROCEDURE

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).

ERCP + ProEUS-GE

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• ECOG 0 or 1
• ASA\<4
• Provision of informed consent

You may not qualify if:

• 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.
• 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.
• Uncorrectable coagulopathy and/or thrombocytopenia
• Age \< 18 or ≥ 85
• Evidence of peritoneal carcinomatosisAscites
• Liver metastasis \> 30% of the liver volume
• Portal hypertension with gastroesophageal varices and/or ascites
• Surgically altered upper gastrointestinal anatomy

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Jewish General Hospital: collaborator
• Unity Health Toronto: collaborator

Study Sites (5)

Jewish General Hospital

Montreal, Canada

NOT YET RECRUITING

McGill University Health Center

Montreal, Canada

RECRUITING

St-Michael's Hospital (SMH)

Toronto, Canada

NOT YET RECRUITING

Hôpital Privé des Peupliers

Paris, France

NOT YET RECRUITING

Asian Institute of Gastroenterology

Hyderabad, India

NOT YET RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Yen-I Chen, MD

CONTACT

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

Myriam Martel, MSc

CONTACT

myriam.martel@muhc.mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: As with most procedural interventional trials, blinding of the endoscopist is not feasible. To limit detection biases, outcome assessors and patients are blinded to the treatment allocation. Outcome assessors are independent individuals not involved with patient consent or randomization and not present at the index procedure.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of medicine

Model Details: Patients will be randomly allocated, intra-procedurally during the ERCP, to one of the two approaches.

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 16, 2023
• Study Start: April 9, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1); CA (3); FR (1)