Botulinum toxin injection to prevent pancreatic fistulas after surgery
Intrapapillary Botulinum Toxin Injection for PREvention of Post-surgical PAncREactic Fistula
This study is testing if botulinum toxin injections can help prevent serious complications after pancreatic surgery for adults who are having a distal pancreatectomy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 460 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Clichy) |
| Trial ID | NCT04220931 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled for distal pancreatectomy.
Not a fit: Patients with certain pre-existing conditions, such as myasthenia gravis or those undergoing specific types of pancreatic surgeries, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the occurrence of postoperative pancreatic fistulas, improving recovery and outcomes for patients undergoing pancreatic surgery.
How similar studies have performed: While various prophylactic strategies for POPF have been attempted, the use of botulinum toxin injections is a novel approach that has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Clichy
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.