Pancreatoduodenectomy with or without prophylactic falciform ligament wrap around the hepatic artery for prevention of postpancreatectomy haemorrhage: randomized clinical trial (PANDA trial).

BACKGROUND: Postpancreatectomy haemorrhage (PPH) is a rare but potentially fatal complication after pancreatoduodenectomy. Preventive strategies are lacking with scarce data for support. The aim of this study was to investigate whether a prophylactic falciform ligament wrap around the hepatic and gastroduodenal artery can prevent PPH from these vessels. METHODS: In a randomized, controlled, multicentre trial, patients who were scheduled for elective open partial pancreatoduodenectomy with pancreatojejunostomy between 5 November 2015 and 2 April 2020 were randomly allocated in a 1 : 1 ratio to undergo pancreatoduodenectomy with (intervention) or without (control) a falciform ligament wrap around the hepatic artery. The primary endpoint was the rate of clinically relevant PPH from the hepatic artery or gastroduodenal artery stump within 3 months after pancreatoduodenectomy. Secondary endpoints were the rates of associated postoperative complications, for example postoperative pancreatic fistula (POPF) and PPH. RESULTS: Altogether, 445 patients were randomized with 222 and 223 in each group. Among the patients included in modified intention-to-treat analysis (207 in the intervention group and 210 in the control group), the primary endpoint was observed in six of 207 in the intervention group compared with 15 of 210 in the control group (2.9 versus 7.1 per cent respectively; odds ratio 0.39 (95 per cent c.i. 0.15 to 1.02); P = 0.071). Per protocol analysis showed a significant reduction in the intervention group (odds ratio 0.26 (95 per cent c.i. 0.09 to 0.80); P = 0.017). A soft pancreas texture (43 per cent) and the rate of a clinically relevant POPF were evenly (20 per cent) distributed between the groups. The rate of any clinically relevant PPH including the primary endpoint and other bleeding sites was not significantly different between intervention and control groups (9.7 versus 14.8 per cent respectively). CONCLUSION: A falciform ligament wrap may reduce PPH from the hepatic artery or gastroduodenal artery stump and should be considered during pancreatoduodenectomy. REGISTRATION NUMBER: NCT02588066 (http://www.clinicaltrials.gov).

A Robotic Camera Holder Controlled by Head Movements: Exploring This New Robot-Surgeon Interface.

Background. Most robotic camera steering devices (RCSDs) require active steering by the surgeon and necessarily increase workload. Clinical experience shows that standard laparoscopic procedures can be performed safely as solo surgery aided by RCSDs. No evidence exists concerning exploratory or emergency procedures. We compared the performance during unexpected laparoscopic tasks on surgical simulators aided either by an RCSD controllable by head movements of the surgeon or by a human camera assistant. Methods. Forty-five medical students without previous experience with minimal invasive surgery were randomized in 2 groups, and they performed standard and unexpected laparoscopic tasks requiring complex camera movements on box trainers either using an RCSD or assisted by a human camera assistant. Efficiency and performance parameters were recorded. Results. Performance in simulated standard procedures was equivalent. In simulated exploratory procedures, we saw significantly better performance scores in the conventional group versus the RCSD group. The strongest factor for these differences was the longer camera-adjusting time in the RCSD group versus the conventional group (PEG task = 208 ± 51 seconds vs 170 ± 36 seconds, P = .005; suture task = 563 ± 126 seconds vs 454 ± 201 seconds, P = .041). Conclusion. These results, obtained on surgical simulators, indicate that the solo approach to standard surgical tasks, facilitated by an RCSD controllable by head movements, can most likely be viewed as safe. Exploratory procedures with a relevant chance for complications or procedures that require rapid, often, or complex camera movements should rather be performed with a human camera assistant.