Trial Title:
Prophylactic EUS-guided Gastroenterostomy in Advanced Periampullary Cancers
NCT ID:
NCT05994521
Condition:
Cancer Gi
Conditions: Keywords:
periampullary cancer
ERCP
EUS-Guided gastroeterostomy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
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.
Primary purpose:
Prevention
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.
Intervention:
Intervention type:
Procedure
Intervention name:
ERCP alone
Description:
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
Arm group label:
ERCP alone
Intervention type:
Procedure
Intervention name:
ERCP +ProEUS-GE
Description:
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 group label:
ERCP + ProEUS-GE
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.
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 is based on the primary endpoint of MGOO considering competing
risk of death. Based on the most current available literature and institutional data, we
estimated a cumulative incidence rate of MGOO of 5% and 25% at 18 months in the ERCP +
ProEUS-GE and ERCP alone arms, respectively. Using a two-sided log-rank test that
accounts for a 35% rate of competing risk (death 30% and surgery 5%) in each group while
considering a loss to follow-up of 10%, with a minimal follow-up time of 1 year, we
calculated that a sample size of 110 patients (55 patients in each arm) is needed to
achieve 80% power at a 0.05 significance level (hazard ratio of 5.6) (nQuery, Boston,
USA). A pre-planned blinded sample size re-estimation will be conducted by members of the
Biostatistics Consulting Unit at the RI-MUHC when approximately 50% of patients have been
evaluated for the primary endpoint. The decision to increase the sample size will be made
by the DSMB independently from any investigators. The study team has no intention of
decreasing the sample size.
For the secondary endpoint of rate of severe adverse event, which is estimated to be 1%
for ERCP alone, a sample size of 110 patients would give us 80% power with a one-sided
significance of 0.05 to detect non-inferiority at a margin of 4.8%.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Jewish General Hospital
Address:
City:
Montreal
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Corey Miller, MD
Facility:
Name:
McGill University Health Center
Address:
City:
Montréal
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Yen-I Chen, MD
Facility:
Name:
St-Michael's Hospital (SMH)
Address:
City:
Toronto
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Natalia C. Calo, MD
Facility:
Name:
Hôpital Privé des Peupliers
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Gianfranco Donatelli, MD
Facility:
Name:
Asian Institute of Gastroenterology
Address:
City:
Hyderabad
Country:
India
Status:
Not yet recruiting
Contact:
Last name:
Sundeep Lakhtakia, MD
Start date:
April 9, 2024
Completion date:
August 2027
Lead sponsor:
Agency:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Agency class:
Other
Collaborator:
Agency:
Jewish General Hospital
Agency class:
Other
Collaborator:
Agency:
Unity Health Toronto
Agency class:
Other
Source:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05994521
