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Clinical Trials in France / NCT05994521
Recruiting Not applicable

Prophylactic EUS-guided Gastroenterostomy in Advanced Periampullary Cancers

NCT05994521 · tracked via the Priya Life Science France tracker
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Phase
Not applicable
Started
2024-04-09
Last updated
2024-10-01

Condition(s) studied

Cancer Gi

Investigational drug(s) / intervention(s)

ERCP aloneERCP +ProEUS-GE

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).

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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.

Trial sites (5)

FacilityCityRegionStatus
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

More McGill University Health Centre/Research Institute of the McGill University Health Centre trials in France

STrategies for Catheter Ablation of peRsistent Atrial Fibrlllation Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05994521 on ClinicalTrials.gov ↗ ← All trials in France