Conventional partial pancreatoduodenectomy versus an extended pancreatoduodenectomy (triangle operation) for pancreatic head cancers—study protocol for the randomised controlled TRIANGLE trial
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 panc...
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2023-05-01
|
| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-023-07337-6 |
| _version_ | 1797811357319430144 |
|---|---|
| author | Patrick Heger Thilo Hackert Markus K. Diener Manuel Feißt Christina Klose Colette Dörr-Harim Friedhelm Möhlenbrock Markus W. Büchler André L. Mihaljevic |
| author_facet | Patrick Heger Thilo Hackert Markus K. Diener Manuel Feißt Christina Klose Colette Dörr-Harim Friedhelm Möhlenbrock Markus W. Büchler André L. Mihaljevic |
| author_sort | Patrick Heger |
| collection | DOAJ |
| description | 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 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. 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 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 registration German Clinical Trials Register DRKS00030576 (UTN U1111-1243-4412) 19th December 2022. |
| first_indexed | 2024-03-13T07:21:28Z |
| format | Article |
| id | doaj.art-a9c91a5f657f4e8e8a66dde23a102736 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-13T07:21:28Z |
| publishDate | 2023-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-a9c91a5f657f4e8e8a66dde23a1027362023-06-04T11:37:50ZengBMCTrials1745-62152023-05-0124111510.1186/s13063-023-07337-6Conventional partial pancreatoduodenectomy versus an extended pancreatoduodenectomy (triangle operation) for pancreatic head cancers—study protocol for the randomised controlled TRIANGLE trialPatrick Heger0Thilo Hackert1Markus K. Diener2Manuel Feißt3Christina Klose4Colette Dörr-Harim5Friedhelm Möhlenbrock6Markus W. Büchler7André L. Mihaljevic8Department of General and Visceral Surgery and Clinical Trial Centre of the Department of General and Visceral Surgery (ulmCARES), University Hospital UlmDepartment of General, Visceral and Transplantation Surgery, University Hospital HeidelbergDepartment of General and Visceral Surgery, University Hospital FreiburgInstitute of Medical Biometry (IMBI), University of HeidelbergInstitute of Medical Biometry (IMBI), University of HeidelbergDepartment of General and Visceral Surgery and Clinical Trial Centre of the Department of General and Visceral Surgery (ulmCARES), University Hospital UlmArbeitskreis der Pankreatektomierten e.VDepartment of General, Visceral and Transplantation Surgery, University Hospital HeidelbergDepartment of General and Visceral Surgery and Clinical Trial Centre of the Department of General and Visceral Surgery (ulmCARES), University Hospital UlmAbstract 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 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. 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 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 registration German Clinical Trials Register DRKS00030576 (UTN U1111-1243-4412) 19th December 2022.https://doi.org/10.1186/s13063-023-07337-6Pancreatic neoplasmsCarcinomaPancreatic ductalPancreaticoduodenectomyRandomised controlled trial |
| spellingShingle | Patrick Heger Thilo Hackert Markus K. Diener Manuel Feißt Christina Klose Colette Dörr-Harim Friedhelm Möhlenbrock Markus W. Büchler André L. Mihaljevic Conventional partial pancreatoduodenectomy versus an extended pancreatoduodenectomy (triangle operation) for pancreatic head cancers—study protocol for the randomised controlled TRIANGLE trial Trials Pancreatic neoplasms Carcinoma Pancreatic ductal Pancreaticoduodenectomy Randomised controlled trial |
| title | Conventional partial pancreatoduodenectomy versus an extended pancreatoduodenectomy (triangle operation) for pancreatic head cancers—study protocol for the randomised controlled TRIANGLE trial |
| title_full | Conventional partial pancreatoduodenectomy versus an extended pancreatoduodenectomy (triangle operation) for pancreatic head cancers—study protocol for the randomised controlled TRIANGLE trial |
| title_fullStr | Conventional partial pancreatoduodenectomy versus an extended pancreatoduodenectomy (triangle operation) for pancreatic head cancers—study protocol for the randomised controlled TRIANGLE trial |
| title_full_unstemmed | Conventional partial pancreatoduodenectomy versus an extended pancreatoduodenectomy (triangle operation) for pancreatic head cancers—study protocol for the randomised controlled TRIANGLE trial |
| title_short | Conventional partial pancreatoduodenectomy versus an extended pancreatoduodenectomy (triangle operation) for pancreatic head cancers—study protocol for the randomised controlled TRIANGLE trial |
| title_sort | conventional partial pancreatoduodenectomy versus an extended pancreatoduodenectomy triangle operation for pancreatic head cancers study protocol for the randomised controlled triangle trial |
| topic | Pancreatic neoplasms Carcinoma Pancreatic ductal Pancreaticoduodenectomy Randomised controlled trial |
| url | https://doi.org/10.1186/s13063-023-07337-6 |
| work_keys_str_mv | AT patrickheger conventionalpartialpancreatoduodenectomyversusanextendedpancreatoduodenectomytriangleoperationforpancreaticheadcancersstudyprotocolfortherandomisedcontrolledtriangletrial AT thilohackert conventionalpartialpancreatoduodenectomyversusanextendedpancreatoduodenectomytriangleoperationforpancreaticheadcancersstudyprotocolfortherandomisedcontrolledtriangletrial AT markuskdiener conventionalpartialpancreatoduodenectomyversusanextendedpancreatoduodenectomytriangleoperationforpancreaticheadcancersstudyprotocolfortherandomisedcontrolledtriangletrial AT manuelfeißt conventionalpartialpancreatoduodenectomyversusanextendedpancreatoduodenectomytriangleoperationforpancreaticheadcancersstudyprotocolfortherandomisedcontrolledtriangletrial AT christinaklose conventionalpartialpancreatoduodenectomyversusanextendedpancreatoduodenectomytriangleoperationforpancreaticheadcancersstudyprotocolfortherandomisedcontrolledtriangletrial AT colettedorrharim conventionalpartialpancreatoduodenectomyversusanextendedpancreatoduodenectomytriangleoperationforpancreaticheadcancersstudyprotocolfortherandomisedcontrolledtriangletrial AT friedhelmmohlenbrock conventionalpartialpancreatoduodenectomyversusanextendedpancreatoduodenectomytriangleoperationforpancreaticheadcancersstudyprotocolfortherandomisedcontrolledtriangletrial AT markuswbuchler conventionalpartialpancreatoduodenectomyversusanextendedpancreatoduodenectomytriangleoperationforpancreaticheadcancersstudyprotocolfortherandomisedcontrolledtriangletrial AT andrelmihaljevic conventionalpartialpancreatoduodenectomyversusanextendedpancreatoduodenectomytriangleoperationforpancreaticheadcancersstudyprotocolfortherandomisedcontrolledtriangletrial |