Clinical trial · Interventional
Simultaneous Resection of Colorectal Cancer With Synchronous Liver Metastases
Simultaneous RESEction of Colorectal Cancer With Synchronous Liver MeTastases (RESECT): A Feasibility Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Synchronous colorectal cancer with liver metastases, defined as the diagnosis of a primary colorectal tumour and liver metastases within 12 months, is a common problem faced by colorectal and hepatobiliary surgeons.(Adam) The "traditional approach" is to perform staged resections unless the liver resection required is limited (i.e. small wedges of peripheral lesions). The downside of performing staged vs. simultaneous resections is that patients must undergo two major operations instead of one, which limits a patient's ability to return to their pre-surgical state of health in a timely fashion, increasing health care costs (Ejaz) and delaying the start of adjuvant chemotherapy. The disadvantages of a simultaneous approach include longer operating room times potentially increasing the major postoperative complication rate including blood transfusions, surgical site infections, anastomotic leaks and post-hepatectomy liver failure. Recent data from tertiary cancer centres suggest that simultaneous resection of the colon and rectum along with liver resection of any magnitude is feasible and safe.(Silberhumer) Although encouraging, this data comes from specific patients from a highly selected institution, results that are perhaps not generalizable. This proposal is a feasibility study consisting of a pilot single arm prospective study at two different large-volume Hepatobiliary Centres of patients with synchronous colorectal cancer with liver metastases undergoing simultaneous resection of the colon or rectum and liver to evaluate their complication rates (including the calculation of the comprehensive complication index), quality of life, cost evaluation, and proportion of eligible patients recruited over a 12-month period. The results of this pilot study will provide us with the information necessary to build a large multicentre randomized controlled trial comparing staged vs. simultaneous resection for synchronous colorectal cancer liver metastases.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ColoRectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Complication | — | UNRESOLVED | — |
| Liver Metastases | — | UNRESOLVED | — |
| Liver Metastasis Colon Cancer | — | UNRESOLVED | — |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Simultaneous Resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Simultaneous Resection
- description
- Patients will undergo resection of the colon or rectum and liver in the same anesthetic setting. The type of colorectal and liver resection will be decided by the treating physician. The type of liver resection will be described according to the Couinaud classification and the Brisbane terminology of liver anatomy.
- interventionNames
- Procedure: Simultaneous Resection
Primary outcomes (1)
- measure
- Comprehensive Complication Index
- timeFrame
- 90 days from the Index Operation
- description
- Postoperative complications used to calculate the Comprehensive Complication Index will be recorded during and following each patient's hospital stay up to 90 days from the index operation and classified according to Clavien-Dindo.(Slankamenac 2013; Dindo; Slankamenac 2014)
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients who present with resectable synchronous colorectal adenocarcinoma and liver metastases. 2. Patients who have a planned resection of their colorectal adenocarcinoma and liver metastases. 3. Patients who are able to provide informed consent. Note: The primary tumour or the liver metastases may require neoadjuvant therapy to become resectable. Patients with the following histology are eligible for the study: adenocarcinoma, adenosquamous carcinoma, mixed adenocarcinoma-neuroendocrine tumour (adenocarcinoma with neuroendocrine differentiation). Patients with suspicious colorectal mass with probably liver metastases in which pathology only shows high grade dysplasia are also eligible as long as a liver resection is contemplated as part of the operative plan. Exclusion Criteria: 1. Extrahepatic disease other than lung. 2. Tumours treated with local transanal excision (patients undergoing transanal total mesorectal excision are eligible). 3. Patients who require a two stage liver resection, prior liver resection. 4. Pregnant or lactating female 5. Absolute contraindications for general anesthesia 6. Patients who require a complex multi-organ pelvic resection, i.e. pelvic exenteration: including bladder, female or male reproductive organs; patients who only require resection of another pelvic organ (including bladder or female reproductive organs or prostate and seminal vesicles) are eligible. 7. Patients undergoing urgent resection of the primary tumour due to bleeding or obstruction in which a simultaneous liver resection is not planned are not eligible for the study, patients who undergo diverting stoma (loop ileostomy or colostomy) prior to resection are eligible.
References
Publications (33)
- BACKGROUNDAdam R, de Gramont A, Figueras J, Kokudo N, Kunstlinger F, Loyer E, Poston G, Rougier P, Rubbia-Brandt L, Sobrero A, Teh C, Tejpar S, Van Cutsem E, Vauthey JN, Pahlman L; of the EGOSLIM (Expert Group on OncoSurgery management of LIver Metastases) group. Managing synchronous liver metastases from colorectal cancer: a multidisciplinary international consensus. Cancer Treat Rev. 2015 Nov;41(9):729-41. doi: 10.1016/j.ctrv.2015.06.006. Epub 2015 Jun 30. PMID 26417845
- BACKGROUNDEjaz A, Semenov E, Spolverato G, Kim Y, Tanner D, Hundt J, Pawlik TM. Synchronous primary colorectal and liver metastasis: impact of operative approach on clinical outcomes and hospital charges. HPB (Oxford). 2014 Dec;16(12):1117-26. doi: 10.1111/hpb.12302. Epub 2014 Jun 26. PMID 24965845
- BACKGROUNDSilberhumer GR, Paty PB, Temple LK, Araujo RL, Denton B, Gonen M, Nash GM, Allen PJ, DeMatteo RP, Guillem J, Weiser MR, D'Angelica MI, Jarnagin WR, Wong DW, Fong Y. Simultaneous resection for rectal cancer with synchronous liver metastasis is a safe procedure. Am J Surg. 2015 Jun;209(6):935-42. doi: 10.1016/j.amjsurg.2014.09.024. Epub 2014 Dec 13. PMID 25601556
- BACKGROUNDManfredi S, Lepage C, Hatem C, Coatmeur O, Faivre J, Bouvier AM. Epidemiology and management of liver metastases from colorectal cancer. Ann Surg. 2006 Aug;244(2):254-9. doi: 10.1097/01.sla.0000217629.94941.cf. PMID 16858188
- BACKGROUNDNordlinger B, Sorbye H, Glimelius B, Poston GJ, Schlag PM, Rougier P, Bechstein WO, Primrose JN, Walpole ET, Finch-Jones M, Jaeck D, Mirza D, Parks RW, Mauer M, Tanis E, Van Cutsem E, Scheithauer W, Gruenberger T; EORTC Gastro-Intestinal Tract Cancer Group; Cancer Research UK; Arbeitsgruppe Lebermetastasen und-tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie (ALM-CAO); Australasian Gastro-Intestinal Trials Group (AGITG); Federation Francophone de Cancerologie Digestive (FFCD). Perioperative FOLFOX4 chemotherapy and surgery versus surgery alone for resectable liver metastases from colorectal cancer (EORTC 40983): long-term results of a randomised, controlled, phase 3 trial. Lancet Oncol. 2013 Nov;14(12):1208-15. doi: 10.1016/S1470-2045(13)70447-9. Epub 2013 Oct 11.