Effect of bile duct clamping versus no clamping on surgical site infections in patients undergoing pancreaticoduodenectomy: a randomized controlled study.

Background: Infectious complications cause significant morbidity after pancreatoduodenectomy (PD). The impact of uncontrolled spillage of bile during PD has not been systematically studied.

Methods: Patients undergoing PD for malignant lesions between March 2017 and May 2019 were considered for inclusion. All patients underwent standard pre-operative preparation and antibiotic prophylaxis. After confirmation of resectability, the patients were randomized into one of the two groups: common hepatic duct clamping using atraumatic bulldog clamp after biliary division (Group I) or no clamping (Group II). Post-operative outcomes including surgical site infection (SSI) were compared.

Results: Fifty-two patients were assessed for eligibility and eventually 40 were randomized (median age: 53.5 years, 28 (70%) males). Twenty patients were randomized into each group and 14 in each group had undergone pre-operative biliary drainage. Incidence of co-morbidities, operative time and blood loss were comparable between the two groups. SSI was significantly lower in Group I (4 (20%) versus 11 (55%), P = 0.02). Number needed to treat to prevent one SSI was 3. Incidence of intra-abdominal collections was higher in Group II, though, not statistically significant (2 (10%) versus 6 (30%), P = 0.23). The duration of post-operative antibiotics was significantly higher in Group II (7 IQR 4 versus 11 IQR 7 days, P = 0.04). Among the risk factor evaluated in the entire population, higher incidence of SSI was seen in patients with positive bile culture (13 (65%) versus 2 (10%), P = 0.04).

Conclusion: Bile duct clamping during PD reduces risk of superficial SSI.