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Prevention study for Pancreatic Fistula
Official title Prevention of Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy by Preoperative Radiotherapy : a Phase 2 Trial
ClinicalTrials.gov ID: NCT07370987
What this study is testing
- What it's testing
- Design of the study Prospective, single arm, multicentric, phase II open trial Number of participating sites 14 French centers of HPB Surgery departments associated with 14 Radiation Oncology Departments. Implementation of the study A screening of eligible patients will be made locally by the referring surgeon of each centre based on patient medical records.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older
You may be able to join if
- Aged ≥ 45 years old
- Candidate for pancreaticoduodenectomy by laparotomy
- Body mass index (BMI) ≥ 25kg/m2
- Diameter of main pancreatic duct (MPD) \< 3 mm on preoperative CT scan or MRI at the isthmus of the pancreas (future pancreatic section area)
- Affiliation to a social security system (AME excepted)
You likely can't join if
- Surgery indication : Chronic pancreatitis
- Surgery indication : Pancreatic ductal adenocarcinoma
- History of syndromic or hereditary pancreatic tumor
- Contraindication to pancreaticoduodenectomy
- Planned multivisceral resection involving organs or parts of organs not normally involved in pancreatico-duodenectomy
- Planned external drainage of the main pancreatic duct at the end of the surgery
See the full eligibility criteria
- Aged ≥ 45 years old
- Candidate for pancreaticoduodenectomy by laparotomy
- Body mass index (BMI) ≥ 25kg/m2
- Diameter of main pancreatic duct (MPD) \< 3 mm on preoperative CT scan or MRI at the isthmus of the pancreas (future pancreatic section area)
- Affiliation to a social security system (AME excepted)
- Signed informed consent
- Surgery indication : Chronic pancreatitis
- Surgery indication : Pancreatic ductal adenocarcinoma
- History of syndromic or hereditary pancreatic tumor
- Contraindication to pancreaticoduodenectomy
- Planned multivisceral resection involving organs or parts of organs not normally involved in pancreatico-duodenectomy
- Planned external drainage of the main pancreatic duct at the end of the surgery
- Neoadjuvant treatment planned or performed by chemotherapy or radiotherapy
- History of chronic hepatitis (F3) or cirrhosis (F4)
- Contraindication to radiotherapy
- Previous history of abdominal radiotherapy
- Extended pancreatic resection on the left beyond the radiotherapy area (left of the pancreatic isthmus)
- History of complicated peptic ulcer
- Patient treated for less than 4 weeks for an ulcer
- History of pancreatic surgery
- Ongoing pregnancy (confirmed by a test beta-HCG) or breast feeding or absence of birth control
- Patients with a active pathology or history that may interfere with the study in progress or the interpretation of its results according to the investigator
- Patients with a history or suspicion of non-compliance with medical regimens or will be unable to complete the entire study
- Treatment with systemic corticosteroids (excluding inhaled corticosteroids)
- Participation in another treatment clinical study (RIPH1, clinical investigation or clinical trial) or exclusion period set after the study
- Protected persons under legal guardianship or conservatorship
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.