NCT04220931 Intrapapillary Botulinum Toxin Injection for PREvention of Post-surgical PAncREactic Fistula
| NCT ID | NCT04220931 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Distal Pancreatectomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 460 participants |
| Start Date | 2023-03-27 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 460 participants in total. It began in 2023-03-27 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. Morbidity is high, postoperative pancreatic fistula (POPF) being the main postoperative complication. In its current definition (drain output of any measurable fluid \>= postoperative day 3 with amylase content \>3 times the serum amylase activity and with clinical consequence), the incidence of postoperative PF is between 15 and 30 %. Most POPF resolve spontaneously but when refractory POPF occurs, it may lead to severe complications. POPF severity is graded as follows: grade B in case of change in medical management: infection without organ failure, specific medication (total parenteral nutrition, somatostatin analogs, antibiotics), persistent drainage \> 3 weeks, angiographic procedure for bleeding, prolonged hospital stay; grade C in case of reoperation or PF-related organ failure or death. No specific prophylactic treatment of POPF is currently recommended by clinical guidelines. In clinical research, many prophylactic strategies have been attempted with partial efficacy. Endoscopic pancreatic sphincterotomy with plastic stent placement is effective in pre-and postoperative management of pancreatic fistula but with the need of a highly competent interventional endoscopist. Intrapapillary botulinum toxin injection is believed to induce relaxation of the pancreatic sphincter, leading to a " pharmacological " pancreatic sphincterotomy without any morbidity. A recent phase I/II prospective study has shown promising results in this indication, with no clinically relevant pancreatic fistula when botulinum toxin was injected. Based on this observation we hypothesize that intrapapillary botulinum toxin injection during an endoscopic procedure before surgery could be effective for the prevention of post-surgical pancreatic fistula
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.
Contact & Investigator
Frederic Prat, prof
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT04220931 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Distal Pancreatectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04220931 currently recruiting?
Yes, NCT04220931 is actively recruiting participants. Contact the research team at frederic.prat@aphp.fr for enrollment information.
Where is the NCT04220931 trial being conducted?
This trial is being conducted at Clichy, France.
Who is sponsoring the NCT04220931 clinical trial?
NCT04220931 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Frederic Prat, prof at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 460 participants.