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

Fudan University

Status

Completed

Conditions

Rectal Neoplasm With Metastasis to the Liver

Treatments

Procedure: simultaneous resection of liver metastasis and the rectal primary tumor

Procedure: staged resection of liver metastasis and the rectal primary tumor

Study type

Interventional

Funder types

Other

Identifiers

NCT00677586

RESONANCE

Details and patient eligibility

About

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.

Full description

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.

Enrollment

180 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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