Clinical trial · Interventional
Evaluation of 2 Resection Strategies of Synchronous Colorectal Cancer Metastases
Prospective Randomized Study Comparing the Morbidity and Mortality After Liver Resection for Synchronous Colorectal Cancer Metastases When Performed Either During or 12 to 14 Weeks After the Primary Resection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Stop recommended following the last sequential analysis
Summary
Brief summary (as posted)
The surgical strategy for the treatment of synchronous colorectal cancer liver metastases has not still been defined. The purpose of this study is to compare two treatment strategies in which liver resection is performed either during, or 12 to 14 weeks after the primary resection. Endpoints include the rate of severe complications and survival.
Conditions
Conditions (2)
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 |
| Hepatic Metastases | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sequential surgery | Procedure | — | UNRESOLVED |
| Simultaneous surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- 1
- description
- Simultaneous surgery of colorectal cancer and synchronous liver metastases
- interventionNames
- Procedure: Simultaneous surgery
- type
- OTHER
- label
- 2
- description
- Sequential surgeries of colorectal cancer and synchronous liver metastases
- interventionNames
- Procedure: Sequential surgery
Primary outcomes (1)
- measure
- Rate of patients with at least one postoperative severe complication within 60 days after each surgery
- timeFrame
- 60 days after each surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male and female adults over 18 years old * At least one adenocarcinoma of colon and/or rectum, histologically proven. * No local complication at the time of surgery (no occlusion, no sub-occlusion, no massive hemorrhage, no abscesses or local invasion) * At least one hepatic metastasis which R0 resection is possible through a conventional simple resection * Informed written consent. Non inclusion criteria: * Heart, Respiratory or Renal failure * Physical or psychological dependence * Chronic liver disease * Extra-hepatic metastases Exclusion Criteria (at time of surgery) * Localized or diffuse peritoneal carcinomatosis * Non resectable lymph node metastases * Colorectal or hepatic tumour extension towards abdominal wall and/or adjacent organ making liver R0 resection impossible immediately * Other hepatic lesions diagnosed with ultrasound making liver R0 resection impossible immediately
References
Publications (2)
- BACKGROUNDMartin R, Paty P, Fong Y, Grace A, Cohen A, DeMatteo R, Jarnagin W, Blumgart L. Simultaneous liver and colorectal resections are safe for synchronous colorectal liver metastasis. J Am Coll Surg. 2003 Aug;197(2):233-41; discussion 241-2. doi: 10.1016/S1072-7515(03)00390-9. PMID 12892803
- BACKGROUNDWeber JC, Bachellier P, Oussoultzoglou E, Jaeck D. Simultaneous resection of colorectal primary tumour and synchronous liver metastases. Br J Surg. 2003 Aug;90(8):956-62. doi: 10.1002/bjs.4132. PMID 12905548