Intrapapillary Botulinum Toxin Injection for PREvention of Post-surgical PAncREactic Fistula

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jan 6, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to prevent a common complication that can happen after pancreatic surgery called postoperative pancreatic fistula (POPF). POPF can occur when pancreatic fluid leaks from the surgical site, which can lead to serious health issues. The trial is testing whether injecting a medication called botulinum toxin into the pancreas before surgery can help relax the pancreatic sphincter and reduce the risk of POPF. This approach aims to be safer than existing methods and has shown promising results in earlier studies.

To participate in this trial, you need to be an adult (18 years or older) scheduled for a specific type of pancreatic surgery called distal pancreatectomy. Certain health conditions, like specific muscle diseases or pregnancy, may exclude you from joining. Participants will receive the botulinum toxin injection during an endoscopic procedure before their surgery and will then be monitored to see if this helps prevent complications. This trial is currently recruiting participants, so if you or a loved one might be eligible, it could be an opportunity to contribute to important research in pancreatic surgery.

Gender

ALL

Eligibility criteria

• 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.