A randomised controlled single blinded multicentre trial of polyethylene glycol sealant to the staple line vs staple line alone in distal pancreatectomy.

Conditions

None listed

Brief summary

Distal pancreatectomy is a surgical procedure commonly used to remove tumours in the body and tail of the pancreas. Postoperative pancreatic fistula formation, where fluid leaks from the remaining pancreas into the abdomen, is the most common and significant surgical complication after this surgery. This can lead to further complications such as intra-abdominal abscess, bleeding, sepsis, and delayed emptying of the stomach. Different techniques have been tried to reduce the rate of POPF. The most successful to date is the use of staples to close the cut edge of the pancreas but the rate of fistula formation continues to be clinically significant. Polyethylene glycol sealants have been successfully used in lung resection surgery to stop air leaks. This type of sealant has not been tested in pancreatic surgery. This study will examine if a polyethylene glycol sealant reduces the rate of postoperative pancreatic fistula formation when used in conjunction with stapling to seal the pancreas.

Furtado R, Weinberg L, Haghighi KS, Burnett D, Croagh D, Muralidharan V, Pilgrim CHC, Sritharan M, Smith M, Perini MV, Yoshino O, Fink MA, Jones R, Lam V, Yuen L, Daly D, Gandy RC, Ban EJ, Houli N, Hodgson R, Privett BJ, PROMETHEUS Research Collaborative, Nikfarjam M.

2025-12-051 citations

10.1111/ans.70419

Interventions

This investigator-initiated, collaborative, randomised, controlled, single-blinded, multicentre trial will test if the use of a polyethylene glycol (PEG) sealant reduces the rate of postoperative pancreatic fistula (POPF) formation in patients undergoing distal pancreatectomy (DP). Patients will be randomised to receive standard staple closure of pancreas or staple closure plus the use of a polyethylene glycol sealant. The application of the surgical sealant will add 5 minutes to the surgical p

This investigator-initiated, collaborative, randomised, controlled, single-blinded, multicentre trial will test if the use of a polyethylene glycol (PEG) sealant reduces the rate of postoperative pancreatic fistula (POPF) formation in patients undergoing distal pancreatectomy (DP). Patients will be randomised to receive standard staple closure of pancreas or staple closure plus the use of a polyethylene glycol sealant. The application of the surgical sealant will add 5 minutes to the surgical procedure. This will be administered as a once only application. This will be applied by the surgical investigator. Record of the application will be recorded in the surgical operation report.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

• 18 years and over • Disease of the pancreatic body or tail with planned treatment with elective distal pancreatectomy • Planned open or minimally invasive approach • Participant able to provide informed consent • Intraoperative completion of a distal pancreatectomy (with or without splenectomy)

Exclusion criteria

• Participation in another trial that might alter the outcome measures of this trial • Pre or intraoperative signs of obstruction of the pancreatic duct at the head of the gland • Unable to provide informed consent or expected lack of compliance with postoperative regime • Distal pancreatic resection with a staple not feasible • Documented allergy to human serum albumin • Renal dysfunction (eGFR <35)

Outcome results