Randomized clinical trials

Balzano G, Zerbi A, Aleotti F, Capretti G, Melzi R, Pecorelli N et al.

Ann Surg 2023; 277: 894-903.

Total pancreatectomy (TP) was associated with reduced perioperative morbidity: 60 versus 90.3%, P=0.008, and similar hospital stay, in this study that included 61 procedures. Survival rates were also similar, but TP was associated with a higher risk of diabetes.

Comment: Intriguing, and could lead to a change in standard care.

Lu X, Jiang J, Shen Z, Chen G, NP YW, Xiao X et al.

Ann Surg 2023; 277: e1200-e1207.

A total of 200 babies with Kasai disease were randomly allocated adjuvant steroids after portoenterostomy. After six months, the proportion of babies who were jaundice-free and had avoided liver transplantation was higher in those treated with steroids: 54.1 versus 31 per cent, P=0.0015.

Comment: Should become routine care.

D’Angelica MI, Ellis RJ, Liu JB, Brajcich BC, Gonen M, Thompson VM et al.

JAMA 2023; 329: 1579-1588.

The trial was stopped after interim analysis of 778 procedures. The combination of piperacillin and tazobactam reduced the risk of surgical site infection at 30 days: 19.8 versus 32.8 per cent, P<0.001. It also reduced the rate of relevant postoperative pancreatic fistula: 12.7 versus 19 per cent, P=0.03.

Comment: Promising new combination for open pancreatic surgery.

Verrastro O, Panunzi S, Castagneto-Gissey L, De Gaetano A, Lembo E, Capristo E et al.

Lancet 2023; 401: 1786-1797.

A total of 288 patients were randomly allocated to best medical therapy or one of two bariatric procedures. Stereohepatitis resolved in 70  per cent of patients who had either Roux-en-Y gastric bypass or sleeve gastrectomy compared to 19 per cent in the best medical treatment group; P<0.0001.

Comment: This study shows convincing evidence that non-alcoholic fatty liver can be reversed by bariatric surgery. Is that alone a reasonable indication?

Serradilla-Martín M, Paterna-López S, Palomares-Cano A, Cantalejo-Díaz M, Abadía-Forcén T, Gutiérrez-Díez ML, et al.

BJS Open 2023; 7: zrad028.

Use of the patch reduced the rate of clinically relevant postoperative pancreatic fistula by 90 per cent; odds ratio 0.1, 95 per cent confidence interval 0.01 to 0.89, P=0.039, in this study that included 64 procedures.

Comment: amazing result, but relatively small series.

Pfister M, Probst P, Muller PC, Antony P, Klotz R, Kalkum E et al. 

BJS Open 2023; 7: zrad007.

This study included 984 patients from six RCTs. Minimally invasive surgery reduced blood loss, surgical site infection (odds ratio 0.4, 95 per cent confidence interval 0.1 to 0.96, P=0.04) and hospital stay by 1.3 days (-2 to -0.5, P=0.001). On average the surgery took 75 minutes longer, P<0.001.

Comment: this is a common result for laparoscopic versus open surgery studies, but a definitive comparison includes late outcomes in cancer cases, and costs (see also Sattari et al).

Sattari SA, Sattari AR, Makary MA, Hu C, He J.

Ann Surg 2023; 277: 742-755.

Four RCTs including 818 procedures were studied. The laparoscopic procedure took longer, but was associated with less blood loss, fewer surgical site infections and reduced length of hospital stay: mean 2.5 days, P=0.06.

Comment: this is a common result for laparoscopic versus open surgery studies, but a definitive comparison includes late outcomes in cancer cases, and costs (see also Pfister et al).

Ghaneh P, Palmer D, Cicconi S, Jackson R, Halloran CM, Rawcliffe C et al, for the European Study Group for Pancreatic Cancer.

Lancet Gastro Hepatol 2023; 8: 157-168.

This study included 83 evaluable patients from 478 screened. Neoadjuvant treatment did not reduce the resection rate. Neoadjuvant treatment improved 1-year disease-free survival in both groups combined: 59 versus 39% for immediate surgery (hazard ratio 0.53, 95 per cent confidence interval 0.28 to 0.98, P=0.016.

Comment: The evidence for neoadjuvant chemotherapy is accumulating, but the number of suitable patients may be small.

Seifert L, von Renesse J, Seifert AM, Sturm D, Meisterfeld R, Rahbari NN et al.

BJS Open 2023; 7: zrac163.

Bile leak rates were similar (14.6 per cent interrupted versus 10.3 per cent continuous sutures) in this study that included 82 procedures.

Comment: No advantage in using interrupted sutures, which took longer.

Nakachi K, Ikeda M, Konishi M, Nomura Skatayama H, Kataoka T, et al  on behalf of the Hepatobiliary and Pancreatic Oncology Group of the Japan Clinical Oncology Group (JCOG-HBPOG).

Lancet 2023; 401: 195-203.

In this study that included 440 procedures, after a median of 45.4 months, adjuvant S-1 therapy given for four cycles improved overall survival from 67.6 to 77.1 per cent, P=0.008.

Comment: A benchmark study for this rare condition, that provides a real hope of improved survival.

Ishii K, Yokoyama Y, Yonekawa Y, Hayashi D, Kinoshita F, Kuwatsuka Y et al.

Br J Surg 2023; 110: 159–165.

This trial that included 218 procedures did not show any difference in intra-operative blood loss with (mean 695ml), or without tranexamic acid (667 ml). Other secondary outcomes were also similar.

Comment: Surprising, since tranexamic acid does seem to be beneficial in most operations with significant blood loss.

Merdrignac A, Garnier J, Dokmak S, Regenet N, Lesurtel M, Mabrut JY, et al.

Ann Surg 2022; 276: 769-775.

Use of the reinforced stapler actually increased the overall rate of pancreatic fistula compared to the standard device: 83 versus 67.7 per cent (P=0.021), in this study that included 199 procedures. The rates of clinically relevant fistula and other complications was similar.

Comment: Disappointing results.

Smits FJ, Henry AC, Besselink MG, Busch OR, van Eijck CH, Arntz M et al, for the Dutch Pancreatic Cancer Group.

Lancet 2022; 399: 1867-1875.

This multicentre study included 1748 pancreatic resections. Use of the algorithm reduced the composite risk of complications from 14 to 8 per cent, relative risk 0.48, 95 per cent confidence interval 0.38 to 0.61, P<0.0001.

Comment: There is no substitute for specialist care.

Van Braak WG, Ponten JEH, Loozen CS, Schots JPM, van Geloven AAW, Donkervoort SC et al.
Br J Surg 2022 109: 267-273.

Some 226 patients with mild to moderate cholecystitis were included. Use of antibiotics reduced the rate of all infections (7.1 versus 12.6 per cent), and in particular surgical site infections (5.3 versus 12.1 percent; P=0.01).

Comment: Antibiotics recommended.

Bressan AK, Isherwood S, Bathe OF, Dixon E, Sutherland FR, Ball C.
Ann Surg 2022; 275: 281-287.

A single preoperative dose of 500mg methylprednisolone reduced the rate of postoperative complications (31.2 versus 47.3 per cent, P=0.042), the rate of organ space site infections (6.5 versus 17.6 per cent, P=0.036) and hospital stay (8.9 versus 12.5 days, P=0.015) in this study that included 151 procedures.

Comment: This is an extraordinary result, and hard to explain on scientific grounds. Fertile ground for more research.

Hewitt, DB, Nissen N, Hatoum H, Musher B, Seng J, Coveler AL et al.
Ann Surg 2022; 275: 45-53.

In this study that included 303 patients, the addition of neoadjuvant immunotherapy did not improve progression-free survival (12. versus 13.4 months in controls) or overall survival (14.3 versus 14.9 months, respectively).

Comment: disappointing negative result.

Toyama H, Matsumoto I, Mizumoto T, Fujita H, Tsuchida S, Kanbara Y, et al.
Ann Surg 2021; 274: 935-944.

This multicentre trial included 212 procedures. The rate of delayed gastric emptying was similar: 15.6 per cent after retrocolic, and 12.6 per cent after antecolic reconstruction. The rates of other complications were also similar.

Comment: Hasn’t this been studied enough now?

Welsch T, Müssle B, Korn S, Sturm D, Bork U.
Br J Surgery 2022; 109: 37-45.

A total of 445 procedures were included. In the intention to treat analysis, there was no significant reduction in haemorrhage (2.9 versus 7.1 per cent, odds ratio 0.39, 95 per cent confidence interval 0.15 to 1.02, P=0.071). In the per protocol analysis the effect was more positive: odds ratio 0.26, 0.09 to 0.8, P=0.017.

Comment: The authors reasonably conclude falciform wrap should be considered during pancreaticoduodenectomy.