Botulinum toxin injection to prevent pancreatic fistulas after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of intrapapillary botulinum toxin injections as a preventive measure against postoperative pancreatic fistula (POPF) in patients undergoing distal pancreatectomy. The study aims to assess the efficacy of this intervention in reducing the incidence and severity of POPF, a common and serious complication following pancreatic surgery. Eligible participants include adults scheduled for distal pancreatectomy, while those with certain medical conditions or prior surgeries are excluded. The trial is conducted at Assistance Publique - Hôpitaux de Paris.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with scheduled distal pancreatectomy for any indication: open or laparoscopic distal pancreatectomy with or without splenectomy
* Age ≥ 18years

Exclusion Criteria:

* 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 4 weeks after the botulinum toxin injection.

Where it's running

• Prat
  Clichy, France Recruiting

Study contacts

• Principal investigator: Frederic Prat, prof — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Frederic Prat, Prof
• Email: frederic.prat@aphp.fr
• Phone: 0033(1)40875663

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Surgery with Islet Autotransplantation for Patients with Pancreatic Cancer

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• Three-day discharge after distal pancreatectomy feasibility and effectiveness

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• Laparoscopic versus robot-assisted left-sided pancreas removal for benign and premalignant lesions

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.