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ERCP + ProEUS-GE for Gastrointestinal Cancer (INTERCEPT Trial)

N/A

Recruiting

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

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

INTERCEPT Trial Summary

This trial aims to see if adding Prophylactic EUS-gastroenterostomy (ProEUS-GE) to the treatment of patients with periampullary cancer can prevent malignant gastric

Who is the study for?

Adults with advanced periampullary cancer not eligible for immediate surgery due to the tumor stage. Participants must have abnormal liver tests needing ERCP but no current gastric outlet obstruction or severe gastroparesis, be in good physical condition (ECOG 0 or 1), and give informed consent.Check my eligibility

What is being tested?

The trial is testing if adding Prophylactic EUS-gastroenterostomy (ProEUS-GE) to standard ERCP treatment can prevent malignant gastric outlet obstruction in patients with advanced periampullary cancer. It's a randomized study comparing two groups: one receiving just ERCP and the other both treatments.See study design

What are the potential side effects?

Potential side effects may include complications from endoscopic procedures like infection, bleeding, pancreatitis, perforation of the gastrointestinal tract, and adverse reactions related to anesthesia.

INTERCEPT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of gastric outlet obstruction (GOO)

Secondary outcome measures

Nutritional status

Quality of life of the participant

Rate of adverse events

INTERCEPT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ERCP + ProEUS-GEExperimental Treatment1 Intervention

ERCP with prophylactic eus-guided gastroenterostomy

Group II: ERCP aloneActive Control1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

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

447 Previous Clinical Trials

159,642 Total Patients Enrolled

Jewish General HospitalOTHER

138 Previous Clinical Trials

272,284 Total Patients Enrolled

Unity Health TorontoOTHER

540 Previous Clinical Trials

447,670 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which specific criteria determine eligibility for participation in this experimental study?

"This research is seeking to enroll 110 individuals aged between 18 and 85 who have gastrointestinal cancer. Notably, interested parties should satisfy certain requirements: ASA score less than 4, Radiological confirmation of periampullary cancer not amenable to curative surgical resection due to advanced stage, such as locally advanced or metastatic tumors in the pancreatic head, distal bile duct, duodenum, or ampulla., Abnormal liver function necessitating ERCP without indications of MGOO or significant gastroparesis (please refer to exclusion criteria #3 and #4), Capacity for informed consent, ECOG performance"

Answered by AI

Do individuals older than 55 years meet the criteria for participation in this study?

"To be eligible for participation in this study, individuals must be aged between 18 and 85 years old."

Answered by AI

Is it presently possible for individuals to enroll in this clinical trial?

"As per clinicaltrials.gov, the ongoing trial is not actively enrolling patients. The study was initially listed on 3/25/2024 and last revised on 3/13/2024. Despite this trial being closed for recruitment, there are five alternative trials open to new participants at present."

Answered by AI

How prevalent are the medical centers conducting this clinical study in our local area?

"The clinical trial is operational at 5 sites, including St-Michael's Hospital (SMH) in Toronto and McGill University Health Center in Montréal. Additionally, the Jewish General Hospital in Montreal is actively participating along with 2 other undisclosed locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prophylactic EUS-guided Gastroenterostomy in Advanced Periampullary Cancers

Yen-I Chen 2024. "Prophylactic EUS-guided Gastroenterostomy in Advanced Periampullary Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05994521.