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

Fudan University180 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

180

Conditions

Rectal Neoplasm With Metastasis to the Liver

Interventions

simultaneous resection of liver metastasis and the rectal primary tumorPROCEDURE

simultaneous resection of liver metastasis and the rectal primary tumor

staged resection of liver metastasis and the rectal primary tumorPROCEDURE

Patients received resection of the rectal tumor. 1 months later received resection of liver metastasis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Severe complication rate after resection of primary and metastatic lesions

Grade of III-V complication rate according to Clavien-Dindo

Time frame: 30 days after surgery

Secondary Outcomes

Disease free survival

Disease free survival after the last resection of primary and metastatic lesions

Time frame: 3 years

Overall survival

Overall survival after the last resection of primary and metastatic lesions

Time frame: 3 years

Post-operative mortality

any death occured within 90 days after the last resection of primary and metastatic lesions

Time frame: 90 days after surgery

Cost of hospitalization

any cost during the resection of primary and metastatic lesions

Time frame: 2 months

Complication rate after resection of primary and metastatic lesions

All grade of complication rate according to Clavien-Dindo

Time frame: 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

Time frame: 30 days after surgery

Data from ClinicalTrials.gov

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