Conventional partial pancreatoduodenectomy versus an extended pancreatoduodenectomy (triangle operation) for pancreatic head cancers—study protocol for the randomised controlled TRIANGLE trial

Trials

Study Protocol

Friedhelm Möhlenbrock¹  Colette Dörr-Harim²  André L. Mihaljevic³  Patrick Heger³  Markus K. Diener⁴  Markus W. Büchler⁵  Thilo Hackert⁵  Christina Klose⁶  Manuel Feißt⁶ 

[1] Arbeitskreis der Pankreatektomierten e.V, Thomas-Mann-Straße 40, 53111, Bonn, Germany;Department of General and Visceral Surgery and Clinical Trial Centre of the Department of General and Visceral Surgery (ulmCARES), University Hospital Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany;Department of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Im Neuenheimer Feld 420, 69120, Heidelberg, Germany;Department of General and Visceral Surgery and Clinical Trial Centre of the Department of General and Visceral Surgery (ulmCARES), University Hospital Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany;Department of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Im Neuenheimer Feld 420, 69120, Heidelberg, Germany;Medical Faculty, Ulm University, Meyerhofstraße M28, 89081, Ulm, Germany;Department of General and Visceral Surgery, University Hospital Freiburg, Hugstetter Straße 55, 79106, Freiburg, Germany;Department of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Im Neuenheimer Feld 420, 69120, Heidelberg, Germany;Institute of Medical Biometry (IMBI), University of Heidelberg, Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany;

关键词: Pancreatic neoplasms;    Carcinoma;    Pancreatic ductal;    Pancreaticoduodenectomy;    Randomised controlled trial;   

DOI  :  10.1186/s13063-023-07337-6

 received in 2023-03-15, accepted in 2023-04-29,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundPancreatic ductal carcinoma (PDAC) is the fourth most frequent cause of cancer-related death in the Western world, and its incidence is rising. In patients that undergo curative resection, local recurrence (LR) is frequent. A recently described surgical technique of extended pancreatoduodenectomy (PD) termed the TRIANGLE operation has been proposed as a promising approach to reduce LR and improve disease-free survival in PDAC patients.MethodsThe TRIANGLE trial is a multicentre confirmatory randomised controlled superiority trial with two parallel study groups. A total of 270 patients with suspected or histologically confirmed pancreatic head cancer scheduled for PD will be included in the trial and randomly assigned to the intervention group (extended PD defined as Inoue level 3 dissection along the superior mesenteric and celiac artery as well as removal of all soft tissue in the so-called triangle between the celiac artery, the SMA and the mesenterico-portal axis) or the control group (conventional PD with lymphadenectomy and removal of soft tissue according to current guidelines). The primary endpoint of the trial will be the disease-free survival of patients. Other perioperative outcomes as well as oncological parameters and patient-reported outcomes will be analysed as secondary outcomes.DiscussionDespite multimodal treatment, LR remains high and disease-free survival is limited following PD for PDAC. The TRIANGLE operation could address these shortcomings of conventional PD as indicated in several retrospective studies. However, this technique could be associated with more adverse events for patients including intractable diarrhoea. The TRIANGLE trial will close the evidence gap as well as offer a risk-benefit assessment of this more radical approach to PD.Trial registrationGerman Clinical Trials Register DRKS00030576 (UTN U1111-1243-4412) 19th December 2022.

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

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Fig. 3