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

Not Applicable

Completed

• Conditions: Rectal Neoplasm With Metastasis to the Liver
• Interventions: Procedure: simultaneous resection of liver metastasis and the rectal primary tumor; Procedure: staged resection of liver metastasis and the rectal primary tumor

• Registration Number: NCT00677586
• Lead Sponsor: Fudan University

Brief Summary

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

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 Timeline

• Study First Submitted: 2008-05-12
• Study First Submitted QC: 2008-05-13
• Study First Posted: 2008-05-14
• Study Start: 2010-07
• Primary Completion: 2020-12-31
• Status Verified: 2022-07
• Study Completion: 2022-07-01
• Last Update Submitted: 2022-07-02
• Last Update Posted: 2022-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	simultaneous resection of liver metastasis and the rectal primary tumor	simultaneous resection of liver metastasis and the rectal primary tumor
2	staged resection of liver metastasis and the rectal primary tumor	staged resection of the liver metastasis and the rectal primary tumor

Primary Outcome Measures

Name	Time	Method
Severe complication rate after resection of primary and metastatic lesions	30 days after surgery	Grade of III-V complication rate according to Clavien-Dindo

Secondary Outcome Measures

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