Clostridium botulinum neurotoxin type A (incobotulinumtoxinA) for Postoperative pancreatic fistula

Inclusion criteria

• {"criterion_text":"- Patients with scheduled distal pancreatectomy for any indication: open or minimally invasive distal pancreatectomy with or without splenectomy"}
• {"criterion_text":"- Age ≥ 18years"}

Exclusion criteria

• {"criterion_text":"- History of myasthenia gravis or Eaton-Lambert syndrome"}
• {"criterion_text":"- Distal pancreatectomy extended to neighbouring organs (except spleen and gallbladder) or to the vessels (celiac axis, portal vein)"}
• {"criterion_text":"- Calcified chronic pancreatitis (suspected on preoperative cross-sectional imaging)"}
• {"criterion_text":"- Pancreas divisum (suspected on preoperative cross-sectional imaging)"}
• {"criterion_text":"- Toxin botulinum contraindications (hypersensitivity to albumin or to saccharose, infection or inflammation at the injection site concerned, generalized muscle weakness)"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Any kind of surgical method to reinforce the pancreatic stump: Use of a bioabsorbable patch, Use of fibrin glue, Use of a ligament patch"}
• {"criterion_text":"- Tutorship, trusteeship"}
• {"criterion_text":"- Concurrent participation in other experimental trials concerning the same objective"}
• {"criterion_text":"- Not Affiliation to the French social security"}
• {"criterion_text":"- Not Ability to give their consent and not written informed consent"}
• {"criterion_text":"- Inflammatory myositis <2 years or preexisting motor neuron disease or neuropathies"}
• {"criterion_text":"- Secondary exclusion criteria: patients who did not have the planned surgery in less than 2 months after the botulinum toxin injection"}
• {"criterion_text":"- ASA score > III"}
• {"criterion_text":"- Pregnancy or lactation"}
• {"criterion_text":"- Altered anatomy of the duodenum and/or the major papilla (prior surgery, prior endoscopic sphincterotomy)"}
• {"criterion_text":"- Scheduled pancreaticoduodenectomy (Whipple procedure)"}
• {"criterion_text":"- Scheduled total pancreatectomy"}
• {"criterion_text":"- Scheduled central pancreatectomy"}
• {"criterion_text":"- Scheduled pancreatic enucleation"}

Primary endpoints

• {"endpoint_text":"- Clinically relevant POPF (grade B and C) in the 3 months after DP.","definition_or_measurement_approach":"Occurrence of clinically relevant postoperative pancreatic fistula (grades B and C) within 3 months after distal pancreatectomy (measured as clinically relevant POPF events during 3-month postoperative follow-up)."}

Secondary endpoints

• {"endpoint_text":"- Grade of postoperative pancreatic fistulas (B, C) based on the ISGPF 2016 update","definition_or_measurement_approach":"Grading of POPF by ISGPF 2016 update criteria."}
• {"endpoint_text":"- Biochemical leak after surgery","definition_or_measurement_approach":"Biochemical leak defined in objectives as a drain output with an amylase content greater than 3 times the serum amylase activity but with no clinical impact."}
• {"endpoint_text":"- Postoperative complications: intra-abdominal fluid collection, delayed gastric emptying, hemorrhage, pancreatitis, wound infection, other infectious complication","definition_or_measurement_approach":"Occurrence of specified postoperative complications during the 3-month postoperative follow-up."}
• {"endpoint_text":"- Clavien-Dindo classification for post-surgical morbidity","definition_or_measurement_approach":"Assessment of postoperative morbidity using the Clavien-Dindo classification."}
• {"endpoint_text":"- Health economics endpoints: duration of hospital stay, hospital readmissions, transfer to intensive care unit and the duration of these stays, fistula-related postoperative invasive procedures, overall costs, the incremental cost utility ratio, the incremental cost effectiveness ratio based upon the clinical endpoint of mortality and post-surgical complication including pancreatic fistula","definition_or_measurement_approach":"Health-economic measures including length of stay, readmissions, ICU transfers/duration, postoperative invasive procedures for fistula, overall costs and incremental cost-utility/effectiveness ratios based on clinical endpoints."}
• {"endpoint_text":"- Quality of life score (EQ5D5L questionnaire)","definition_or_measurement_approach":"Quality of life measured using the EQ-5D-5L questionnaire."}
• {"endpoint_text":"- Postsurgical mortality (30 and 90-day)","definition_or_measurement_approach":"All-cause postsurgical mortality assessed at 30 and 90 days postoperatively."}
• {"endpoint_text":"- Side effects related to the endoscopic botulinum toxin injection","definition_or_measurement_approach":"Recording and assessment of adverse events related to the endoscopic botulinum toxin injection during follow-up."}

France

Earliest CTIS Part Ii Submission Date

30-09-2024

Latest Decision Or Authorization Date

01-08-2025

Processing Time Days

305

Number Of Sites

21

Number Of Participants

460

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"Programme Hospitalier de Recherche Clinique PHRC 2017 (Ministry of Health)","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"MERZ France","duties_or_roles":"Source of monetary support","organisation_type":""}