Clinical trial · Interventional
Simultaneous Versus Staged Resection for Initially Resectable Synchronous Rectal Cancer Liver-limited Metastasis
Simultaneous Versus Staged Resection for Initially Resectable Synchronous Rectal Cancer Liver-limited Metastasis: A Randomized Controlled Trial
NCT00677586CI-TRIAL-00059530completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to investigate the safety and efficacy of simultaneous liver resections compared to staged hepatectomies of rectal cancer with liver metastasis and to compare the short and long-term survival between the two groups.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Neoplasm With Metastasis to the Liver | Rectal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| simultaneous resection of liver metastasis and the rectal primary tumor | Procedure | — | UNRESOLVED |
| staged resection of liver metastasis and the rectal primary tumor | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- simultaneous resection of liver metastasis and the rectal primary tumor
- interventionNames
- Procedure: simultaneous resection of liver metastasis and the rectal primary tumor
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- staged resection of the liver metastasis and the rectal primary tumor
- interventionNames
- Procedure: staged resection of liver metastasis and the rectal primary tumor
Primary outcomes (1)
- measure
- Severe complication rate after resection of primary and metastatic lesions
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * age\>=18 and \<= 75 years * resectable primary rectal tumor * remnant liver volume \>= 60% * without other organ metastasis or peritoneum metastasis * without contradiction of cardiac and pulmonary diseases * American Society of Anesthesiologists (ASA) class I - II * Histologically proved rectal adenocarcinoma Exclusion Criteria: * age \> 75 years * unresectable primary rectal tumor * remnant liver volume \< 60% * with other organ metastasis or peritoneum metastasis * with contradiction of cardiac and pulmonary diseases * Tumors assessed as clinical complete response after preoperative radio- or chemoradiotherapy * Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery * Multiple colorectal tumors or other schedules needing for synchronous colon surgery * Co-existent inflammatory bowel disease * Pregnancy or lactation * Patients received treatment other than preoperative radio- or chemoradiotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.