Pasireotide does not prevent postoperative pancreatic fistula: a prospective study

Area of Science:

• Gastroenterology
• Surgical Oncology
• Clinical Pharmacology

Background:

• Pancreatic fistula is a significant complication following pancreatic surgery.
• A prior study suggested pasireotide could reduce pancreatic fistula rates, but this requires validation.
• Pasireotide has not achieved widespread adoption for this indication.

Purpose of the Study:

• To validate the efficacy of pasireotide in preventing pancreatic fistula after pancreatic resection.
• To assess the safety and tolerability of pasireotide in this patient population.

Main Methods:

• A single-arm prospective study of 111 patients receiving 900 μg subcutaneous pasireotide twice daily perioperatively.
• Comparison of fistula rates with 168 historical controls.
• Primary outcome: Grade B/C pancreatic fistula, defined by the International Study Group on Pancreatic Fistula (ISGPF).

Main Results:

• No significant difference in pancreatic fistula rates between the pasireotide group (17.1%) and historical controls (15.5%), p=0.72.
• Subgroup analyses (pancreaticoduodenectomy, distal pancreatectomy, soft gland texture, small duct size) showed no reduction in fistula rates.
• Dose-limiting nausea occurred in 38% of patients receiving pasireotide.

Conclusions:

• Pasireotide failed to demonstrate efficacy in preventing pancreatic fistula in this adequately powered prospective study.
• The findings do not support the use of pasireotide for pancreatic fistula prevention after pancreatic resection.
• Safety concerns, including nausea, were noted with pasireotide administration.