Cancer GiINTERCEPTNCT05994521
Prophylactic EUS-guided Gastroenterostomy in Advanced Periampullary Cancers
A study testing ERCP alone and ERCP +ProEUS-GE in people with Cancer Gi, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 5 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cancer Gi
- What is being tested?
- ERCP alone and ERCP +ProEUS-GE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 9 Apr 2024to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Myriam Martel, MSc contact
5 sites in 3 countries
Canada3 sites, 3 recruiting
- Not yet recruiting
Jewish General Hospital
Montreal
Corey Miller, MD
- Recruiting
McGill University Health Center
Montreal
Yen-I Chen, MD
- Not yet recruiting
St-Michael's Hospital (SMH)
Toronto
Natalia C. Calo, MD
France1 site, 1 recruiting
- Not yet recruiting
Hôpital Privé des Peupliers
Paris
Gianfranco Donatelli, MD
India1 site, 1 recruiting
- Not yet recruiting
Asian Institute of Gastroenterology
Hyderabad
Sundeep Lakhtakia, MD
About this study
Official title: Prophylactic EUS-guided Gastroenterostomy in Advanced Periampullary Cancers: a Multicenter Randomized Controlled Trial
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?
Read more
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.
Read the 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%.
- Conditions
- Cancer Gi
- Being tested
- ERCP alone, ERCP +ProEUS-GE
- Keywords
- periampullary cancer, ERCP, EUS-Guided gastroeterostomy
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCP aloneProcedure or surgery
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-GEProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: ERCP alone |
| ERCP + ProEUS-GE | Experimental | ERCP with prophylactic eus-guided gastroenterostomy Receives: Procedure: ERCP +ProEUS-GE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (3)
Rate of adverse events
Adverse events are defined and rated according to the ASGE lexicon for endoscopic adverse events.
Measured: 18 months
Quality of life of the participant
Quality of life will be assessed through the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life of Cancer Patients questionnaire. The EQ-5D-5L will also be used to obtain Health Related Quality of Life (HRQoL) or health utilities
Measured: 18 months
Nutritional status
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start9 Apr 2024
- Primary completionFeb 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer GiStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly allocated, intra-procedurally during the ERCP, to one of the two approaches.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Jewish General Hospital, Unity Health Toronto
- Responsible party
- Principal investigator, Yen-I Chen, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05994521
- Sponsor's protocol ID
- MP-37-2024-9711
- Acronym
- INTERCEPT
- Status last verified
- Sep 2024
- First submitted
- 8 Aug 2023
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic EUS-guided Gastroenterostomy in Advanced Periampullary Cancers: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05994521
- Acronym / sponsor ID
- INTERCEPT / MP-37-2024-9711
- Conditions
- Cancer Gi
- Keywords
- periampullary cancer, ERCP, EUS-Guided gastroeterostomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Jewish General Hospital, Unity Health Toronto
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomly allocated, intra-procedurally during the ERCP, to one of the two approaches.
| Arm | Type | Receives |
|---|---|---|
| ERCP alone | Active comparator | Procedure: ERCP aloneERCP procedure alone and management of MGOO will be on a wait-and-see approach, using endoscopic interventions performed only if obstruction is clinically diagnosed |
| ERCP + ProEUS-GE | Experimental | Procedure: ERCP +ProEUS-GEERCP with prophylactic eus-guided gastroenterostomy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERCP aloneERCP 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 | Procedure or surgery | ERCP alone |
| ERCP +ProEUS-GEERCP 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). | Procedure or surgery | ERCP + ProEUS-GE |
Primary outcome
Rate of gastric outlet obstruction (GOO)
Time frame: 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.
3 secondary outcomes
Rate of adverse events
Time frame: 18 months
Quality of life of the participant
Time frame: 18 months
Nutritional status
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Myriam Martel, MSc contact
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERCP alone and ERCP +ProEUS-GE in people with Cancer Gi, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada, France, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yen-I Chen, MD ((514) 934-1934 ext. 65651, yen-i.chen@mgcill.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of gastric outlet obstruction (GOO) (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.