Simultaneous Versus Staged Resection for Initially Resectable Synchronous Rectal Cancer Liver-limited Metastasis

Study Overview
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Brief Summary
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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.

Detailed Description
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The optimal surgical strategy for treatment of patients with resectable synchronous rectal liver metastases remains controversial. To answer whether synchronous rectal cancer liver metastases (SLM) should be resected simultaneously with primary cancer or should be delayed, We conducted a randomized, controlled trial to compare the safety and efficacy of simultaneous versus delayed resection of the rectum and liver. Patients with rectal cancer and resectable SLM were randomly assigned to either simultaneous or delayed resection of the metastases. The primary outcome was the rate of major complications (Clavien-Dindo grade≥III) within 30 days following surgery. Secondary outcomes included disease-free and overall survival. A consecutive patients of rectal cancer with liver metastasis from ZhongShan hospital, Fudan university were enrolled and randomly assigned to simultaneous liver resections and staged hepatectomies. Post-operative complications, peri-operative mortality, long-term survival were compared.

Official Title
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Simultaneous Versus Staged Resection for Initially Resectable Synchronous Rectal Cancer Liver-limited Metastasis: A Randomized Controlled Trial

Conditions
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Rectal Neoplasm With Metastasis to the Liver

Intervention / Treatment
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* Procedure: simultaneous resection of liver metastasis and the rectal primary tumor
* Procedure: staged resection of liver metastasis and the rectal primary tumor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Rectal cancer patients with synchronous resectable liver metastasis were randomized to simultaneous resection of primary and metastatic lesions or staged resection
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>simultaneous resection of liver metastasis and the rectal primary tumor | Procedure: simultaneous resection of liver metastasis and the rectal primary tumor<br>* simultaneous resection of liver metastasis and the rectal primary tumor<br>|
| Active Comparator: 2<br>staged resection of the liver metastasis and the rectal primary tumor | Procedure: staged resection of liver metastasis and the rectal primary tumor<br>* Patients received resection of the rectal tumor. 1 months later received resection of liver metastasis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe complication rate after resection of primary and metastatic lesions | Grade of III-V complication rate according to Clavien-Dindo | 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival | Disease free survival after the last resection of primary and metastatic lesions | 3 years | 
| Overall survival | Overall survival after the last resection of primary and metastatic lesions | 3 years | 
| Post-operative mortality | any death occured within 90 days after the last resection of primary and metastatic lesions | 90 days after surgery | 
| Cost of hospitalization | any cost during the resection of primary and metastatic lesions | 2 months | 
| Complication rate after resection of primary and metastatic lesions | All grade of complication rate according to Clavien-Dindo | 30 days after surgery | 
| Postoperative hospital stay | The postoperative hospital stay is defined as the number of date from the first day after operation to discharge | 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rectal neoplasms, liver metastasis, surgery, simultaneous resection, staged resection