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

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.

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