Informations générales (source: ClinicalTrials.gov)
Intrapapillary Botulinum Toxin Injection for PREvention of Post-surgical PAncREactic Fistula
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
mars 2023
mars 2027
12 septembre 2025
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
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP Assistance publique - Hôpitaux de Paris | 13/12/2025 07:52:45 | Contacter | |||
| AP-HP - Hôpital Beaujon | |||||
| AP-HP - Hôpital Cochin | |||||
| AP-HP - Hôpital La Pitié-Salpêtrière | |||||
| AP-HP - Hôpital Saint Antoine | |||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| PRAT - 92110 - Clichy - France | Frederic Prat, pr | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Patients with scheduled distal pancreatectomy for any indication: open or
laparoscopic distal pancreatectomy with or without splenectomy
- Age ≥ 18years
- 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
4 weeks after the botulinum toxin injection.