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Prevention study for Distal Pancreatectomy
Official title Intrapapillary Botulinum Toxin Injection for PREvention of Post-surgical PAncREactic Fistula
ClinicalTrials.gov ID: NCT04220931
What this study is testing
What is botulinum toxin injection?
botulinum toxin injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for distal pancreatectomy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Surgery is required for the treatment of many pancreatic conditions, either malignant or benign. Mortality of pancreatic surgery can be up to 3% even in expert centers.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with scheduled distal pancreatectomy for any indication: open or laparoscopic distal pancreatectomy with or without splenectomy
- Age ≥ 18years
You likely can't join if
- History of myasthenia gravis or Eaton-Lambert syndrome
- Inflammatory myositis \<2 years or preexisting motor neuron disease or neuropathies
- 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)
See the full eligibility criteria
- Patients with scheduled distal pancreatectomy for any indication: open or laparoscopic distal pancreatectomy with or without splenectomy
- Age ≥ 18years
- History of myasthenia gravis or Eaton-Lambert syndrome
- Inflammatory myositis \<2 years or preexisting motor neuron disease or neuropathies
- 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
- 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
- Not Affiliation to the French social security
- Not Ability to give their consent and not written informed consent
- Distal pancreatectomy extended to neighbouring organs (except spleen and gallbladder) or to the vessels (celiac axis, portal vein) Secondary exclusion criteria: patients who did not have the planned surgery in less than...
The study team makes the final eligibility decision.
Where it's taking place
- Clichy, 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clichy, 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.