BridgeMD
PREPARE - Intrapapillary botulinum toxin injection for PREvention of post-surgical PAncREatic fistula
EU CTIS ID: 2024-514929-33-00
What this study is testing
To study the efficacy of intrapapillary botulinum toxin injection for the prevention of postoperative pancreatic fistula (grade B and C) in the 3 months after distal pancreatectomy (DP).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with scheduled distal pancreatectomy for any indication: open or minimally invasive distal pancreatectomy with or without splenectomy
- Age ≥ 18years
You likely can't join if
- History of myasthenia gravis or Eaton-Lambert syndrome
- Distal pancreatectomy extended to neighbouring organs (except spleen and gallbladder) or to the vessels (celiac axis, portal vein)
- Calcified chronic pancreatitis (suspected on preoperative cross-sectional imaging)
- Pancreas divisum (suspected on preoperative cross-sectional imaging)
- Toxin botulinum contraindications (hypersensitivity to albumin or to saccharose, infection or inflammation at the injection site concerned, generalized muscle weakness)
- Preoperative administration of somatostatin analogs: for long-acting somatostatin analogs, a 1-month washout period is necessary; for short-acting somatostatin analogs, a 24-hours washout period is necessary
See the full eligibility criteria
- Patients with scheduled distal pancreatectomy for any indication: open or minimally invasive distal pancreatectomy with or without splenectomy
- Age ≥ 18years
- History of myasthenia gravis or Eaton-Lambert syndrome
- Distal pancreatectomy extended to neighbouring organs (except spleen and gallbladder) or to the vessels (celiac axis, portal vein)
- Calcified chronic pancreatitis (suspected on preoperative cross-sectional imaging)
- Pancreas divisum (suspected on preoperative cross-sectional imaging)
- Toxin botulinum contraindications (hypersensitivity to albumin or to saccharose, infection or inflammation at the injection site concerned, generalized muscle weakness)
- Preoperative administration of somatostatin analogs: for long-acting somatostatin analogs, a 1-month washout period is necessary; for short-acting somatostatin analogs, a 24-hours washout period is necessary
- Any kind of surgical method to reinforce the pancreatic stump: Use of a bioabsorbable patch, Use of fibrin glue, Use of a ligament patch
- Tutorship, trusteeship
- Concurrent participation in other experimental trials concerning the same objective
- Not Affiliation to the French social security
- Not Ability to give their consent and not written informed consent
- Inflammatory myositis <2 years or preexisting motor neuron disease or neuropathies
- Secondary exclusion criteria: patients who did not have the planned surgery in less than 2 months after the botulinum toxin injection
- ASA score > III
- Pregnancy or lactation
- Altered anatomy of the duodenum and/or the major papilla (prior surgery, prior endoscopic sphincterotomy)
- Scheduled pancreaticoduodenectomy (Whipple procedure)
- Scheduled total pancreatectomy
- Scheduled central pancreatectomy
- Scheduled pancreatic enucleation
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.