Conventional partial pancreatoduodenectomy versus an extended pancreatoduodenectomy (triangle operation) for pancreatic head cancers – the randomized controlled TRIANGLE trial
Organizational Data
- DRKS-ID:
- DRKS00030576
- Recruitment Status:
- Recruiting planned
- Date of registration in DRKS:
- 2022-12-19
- Last update in DRKS:
- 2024-02-05
- Registration type:
- Prospective
Acronym/abbreviation of the study
TRIANGLE
URL of the study
No Entry
Brief summary in lay language
Pancreatic cancer is the fourth most common cause of cancer death in Germany with an increasing incidence. In more than 50% of patients, a disease stage with distant metastases is already present at the time of diagnosis, so that only palliative chemotherapy can be given. After surgical therapy, which is the only curative approach, one of the main reasons for disease recurrence is local recurrence, with most local recurrences found in the soft tissue area along the coeliac trunk and superior mesenteric artery. Therefore, it is believed that radical resection in this area could lead to a lower risk of local recurrence. Such a radical resection, in which all soft tissue in this "triangle" is removed, has not yet been investigated in a randomized-controlled trial in the surgical treatment of pancreatic cancer. The TRIANGLE trial is therefore designed to investigate the effect of such therapy with respect to recurrence rate and survival of patients with pancreatic cancer. With equal severity of adverse effects, if disease-free time improves, more extended Whipple's surgery could become the new standard of care for affected patients.
Brief summary in scientific language
The multicentre randomised controlled TRIANGLE trial aims to evaluate whether a more radical dissection along the superior mesenteric artery (SMA) and removal of all lymphatic and soft tissue between the celiac artery (CA), the mesenterico-portal axis (MPA) and the SMA (the so called “triangle”) during partial pancreaticoduodenectomy (PD) in comparison to conventional PD increases disease-free survival (DFS) in patients with carcinomas of the pancreatic head.
Health condition or problem studied
- ICD10:
- C25.0 - Head of pancreas
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- Triangle procedure: Partial pancreatoduodenectomy with - Radical soft tissue dissection along the superior mesenteric artery (level 3 as described by Inoue et al.) for at least 180 degree on the right (5 to 11 o’clock) AND - Complete dissection of the soft tissue between celiac artery/trunk, SMA and the mesenterico-portal axis
- Arm 2:
- Control intervention (standard Whipple): - Standard dissection of the SMA according to Inoue level 1 or 2 - Standard lymphadenectomy according to German S3-guidelines
Endpoints
- Primary outcome:
- Disease free survival (DFS) after index operation, defined as the time from randomisation until disease recurrence (local recurrence or metastases) or death from any cause
- Secondary outcome:
- 1. Rate of a. microscopically complete circumferential resection margin (CRM) clearance (>0.1cm margin clearance, R0(CRM-)) b. microscopic margin clearance ≤0.1cm (R0(CRM+)) c. microscopic margin involvement (R1) resections according to the 8th edition of the UICC TNM classification 2. Rate of the following PD-associated postoperative complications within 90 days after the index operation: a. Postoperative pancreatic fistula (POPF) as defined by the International Study Group of Pancreatic Surgery (ISGPS) b. Postpancreatectomy haemorrhage (PPH) as defined by the ISGPS c. Delayed gastric emptying as defined by the ISGPS d. Bile leakage as defined by the International Study Group of Liver Surgery (ISGLS) e. Lymphatic fistula as defined by the ISGPS f. Diarrhoea as graded by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 3. All other postoperative complications graded according to the Dindo-Clavien classification within 90 days 4. Overall survival within study period 5. Local recurrence within study period 6. Quality of life according to EORTC QLQ-C30 and PAN26 7. Quality of recovery according to QoR-15 questionnaire 8. Length of primary hospital stay 9. Serious adverse events in both groups
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Assessor
- Patient/subject
Recruitment
- Recruitment Status:
- Recruiting planned
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Klinik für Allgemeine, Viszeral- und Transplantationschirurgie Tübingen
Recruitment period and number of participants
- Planned study start date:
- 2024-03-31
- Actual study start date:
- No Entry
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 270
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Preoperative inclusion criteria: − Patients with suspected or histologically verified resectable, borderline or locally advanced pancreatic cancer of the pancreatic head (i.e. pancreatic ductal adenocarcinoma, IPMN (Intraductal Papillary Mucinous Neoplasms) carcinoma or periampullary cancer of the pancreatobiliary-type) − Patients scheduled for elective partial pancreatoduodenectomy (irrespective of neoadjuvant therapy) − Assumed resectability in accordance with the surgical protocol for experimental and control intervention as judged by the treating surgeon − Ability of subject to understand character and individual consequences of the clinical trial − Written informed consent − Age ≥18 years Intraoperative inclusion criteria (prior to randomisation): − No distant metastases − No paraaortic lymph node metastases − Intraoperative confirmation that the patient can be operated according to both surgical methods (experimental or control group)
Exclusion Criteria
- Participation in another interventional trial with interference of intervention and outcome of this trial − American Society of Anesthesiologists (ASA) grade > 3 − Distant metastatic disease
Addresses
Primary Sponsor
- Address:
- Klinik für Allgemeine, Viszeral- und Transplantationschirurgie, Universitätsklinikum TübingenProf. Dr. med. André MihaljevicHoppe-Seyler-Straße 372074 TübingenGermany
- Telephone:
- +4970712986620
- Fax:
- +4970712986620
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Klinik für Allgemeine, Viszeral- und Transplantationschirurgie, Universitätsklinikum TübingenProf. Dr. André MihaljevicHoppe-Seyler-Straße 372074 TübingenGermany
- Telephone:
- +4970712986620
- Fax:
- +4970712986620
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Klinik für Allgemeine, Viszeral- und Transplantationschirurgie, Universitätsklinikum TübingenProf. Dr. André MihaljevicHoppe-Seyler-Straße 372074 TübingenGermany
- Telephone:
- +4970712986620
- Fax:
- +4970712986620
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Klinik für Allgemeine, Viszeral- und Transplantationschirurgie, Universitätsklinikum TübingenProf. Dr. André MihaljevicHoppe-Seyler-Straße 372074 TübingenGermany
- Telephone:
- +4970712986620
- Fax:
- +4970712986620
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- BMBF - DLR ProjektträgerHeinrich-Konen-Straße 153227 BonnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Universität UlmHelmholtzstr. 2089081 UlmGermany
- Telephone:
- +49-731-50022050
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2022-12-05
- Ethics committee number:
- 404/22
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2022-12-07
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- Anonymous data will be publicly available for re- and meta-analyses after completion of the trial
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry