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

Sep 28, 2026

Uploaded by Margaret

Pancreatic ductal carcinoma (PDAC) causes substantial cancer-related mortality and incidence is rising, with frequent local recurrence after curative resection. The TRIANGLE operation, an extended pancreatoduodenectomy technique, has been proposed to reduce local recurrence and improve disease-free survival. The TRIANGLE trial is a multicentre randomised controlled superiority study enrolling 270 patients scheduled for PD. Participants receive either extended PD with defined vascular-area dissection and complete soft-tissue removal, or conventional PD with lymphadenectomy and guideline-based soft-tissue removal. Disease-free survival is the primary endpoint, with perioperative, oncological, and patient-reported outcomes as secondary endpoints.

LanguageEnglish

CategoryHealthcare

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Pages15

Reading Time38 min

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Abstract

Background

Methods

Discussion

Administrative information

Heger et al. Trials (2023) 24:363 [https://doi.org/10.1186/s13063-023-07337-6](https://doi.org/10.1186/s13063-023-07337-6) Trials STUDY PROTOCOL Open Access Conventional partial pancreatoduodenectomy versus an extended pancreatoduodenectomy (triangle operation) for pancreatic head cancers—study protocol for the randomised controlled TRIANGLE trial Patrick Heger1,2,3, Thilo Hackert2, Markus K. Diener4, Manuel Feißt5, Christina Klose5, Colette Dörr‑Harim 1,2, Friedhelm Möhlenbrock6, Markus W. Büchler2 and André L. Mihaljevic 1,2,3* Abstract Background Pancreatic 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. Methods The 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 trian‑ gle 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. Discussion Despite 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 ret‑ rospective 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 registration German Clinical Trials Register DRKS00030576 (UTN U1111‑1243‑4412) 19th December 2022. Keywords Pancreatic neoplasms, Carcinoma, Pancreatic ductal, Pancreaticoduodenectomy, Randomised controlled trial *Correspondence: André L. Mihaljevic andre. mihaljevic@uni‑[ulm.de](ulm.de) Full list of author information is available at the end of the article © The Author(s) 2023. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit [http://creativecommons.org/licenses/by/4.0/](http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ()[. The Creative Commons Public Domain Dedication waiver (](http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ()[http://creativeco](http://creativeco)[mmons.org/publicdomain/zero/1.0/](mmons.org/publicdomain/zero/1.0/)) app

FAQs

What problem does the TRIANGLE trial address in pancreatic ductal carcinoma surgery?

Local recurrence remains frequent and disease-free survival is limited after conventional partial pancreatoduodenectomy. The trial evaluates whether the TRIANGLE operation can improve these outcomes.

How are patients assigned in the TRIANGLE trial?

A total of 270 patients with suspected or histologically confirmed pancreatic head cancer scheduled for pancreatoduodenectomy are randomly assigned to either the intervention group (extended PD) or the control group (conventional PD).

What is the primary endpoint and what are the secondary outcomes?

The primary endpoint is disease-free survival. Secondary outcomes include perioperative outcomes, oncological parameters, and patient-reported outcomes.

Sep 28, 2026

Uploaded by Margaret