INTERCEPT: Prophylactic EUS-guided Gastroenterostomy in Advanced Periampullary Cancers

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05994521

Collaborator

Jewish General Hospital (Other), Unity Health Toronto (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Gi	Procedure: ERCP alone Procedure: ERCP +ProEUS-GE	N/A

Detailed Description

Research Question:

The principal research question is whether ProEUS-GE can prevent the occurrence of MGOO in patients with pancreatic head cancer. We hypothesize that the addition of ProEUS-GE during ERCP reduces the rate of development of subsequent MGOO in advanced periampullary solid cancer without significantly increasing the rate of adverse events when compared to ERCP alone.

The Proposed Trial Trial Design: This is a patient- and outcome assessor-blinded multicentre randomized controlled superiority trial. The endoscopist performing the procedure will not be blinded to treatment allocation.

Planned Trial Interventions: 1) ERCP with biliary decompression + prophylactic EUS-guided gastroenterostomy (ProEUS-GE) and 2) ERCP with biliary decompression alone. All procedures will be performed by experienced endoscopists with or without trainee involvement. Following informed consent, sedation will be via conscious sedation or general anesthesia, as per existing institutional procedural protocols. A medical effectiveness approach will be adopted where only the initial randomly allocated treatment is dictated by the trial.

Participant Allocation: After confirmation of fulfillment of all study inclusion/exclusion criteria and pre-procedural consent, patients will be randomly allocated, intra-procedurally during the ERCP, to one of the two approaches.

The primary endpoint is the rate of gastric outlet obstruction.

Sample Size Calculation:

Using the currently available data in the literature and local data from the MUHC, we estimate a MGOO risk of 5% vs. 30% with ERCP + ProEUS-GE vs. ERCP alone, respectively, up to 18 months of follow-up. To achieve a statistical power of 80% with a two-sided type I error of 5% while considering a loss to follow-up of 5%, a final sample size of 74 patients (37 patients in each arm) is needed.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Prevention

Official Title:

Prophylactic EUS-guided Gastroenterostomy in Advanced Periampullary Cancers: A Multicenter Randomized Controlled Trial

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2027

Anticipated Study Completion Date :

Feb 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
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	Procedure: 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
Experimental: ERCP + ProEUS-GE ERCP with prophylactic eus-guided gastroenterostomy	Procedure: 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).

Arm

Intervention/Treatment

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

Procedure: 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

Experimental: ERCP + ProEUS-GE

ERCP with prophylactic eus-guided gastroenterostomy

Procedure: 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).

Outcome Measures

Primary Outcome Measures

Rate of gastric outlet obstruction (GOO) [18 months]
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.

Secondary Outcome Measures

Rate of adverse events [18 months]
Adverse events are defined and rated according to the ASGE lexicon for endoscopic adverse events.
Quality of life of the participant [18 months]
Quality of life will be assessed through the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life of Cancer Patients questionnaire
Nutritional status [18 months]
Nutritional status will be assessed using the patient-generated subjective global assessment short form (PG-SGA). The PG-SGA scoring scales from 0 to >9, with a higher score indicating a need for symptom management or nutritional intervention. We will also assess for sarcopenia by incorporating objective quantification of muscle and adipose tissue compartments. These compartments have been shown to have significant prognostic value in patients with pancreatic cancer, including overall survival.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria (all of the following):

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.
Elevated liver function tests requiring ERCP without evidence of MGOO of significant gastroparesis (see exclusion criterion #3 and #4)
ECOG 0 or 1
ASA<4
Provision of informed consent

Exclusion Criteria (any of the following):

Resectable periampullary cancer
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
Ascites > grade I
Liver metastasis > 30% of the liver volume
Portal hypertension with gastroesophageal varices and/or ascites
Surgically altered upper gastrointestinal anatomy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

McGill University Health Centre/Research Institute of the McGill University Health Centre
Jewish General Hospital
Unity Health Toronto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yen-I Chen, assistant professor of medicine, McGill University Health Centre/Research Institute of the McGill University Health Centre

ClinicalTrials.gov Identifier:

NCT05994521

Other Study ID Numbers:

MP-37-2024-9711

First Posted:

Aug 16, 2023

Last Update Posted:

Aug 18, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yen-I Chen, assistant professor of medicine, McGill University Health Centre/Research Institute of the McGill University Health Centre

periampullary cancer

ERCP

EUS-Guided gastroeterostomy

Study Results

No Results Posted as of Aug 18, 2023