Robot-assisted Procedure Versus Open Simultaneous Resection of Colorectal Cancer With Liver Metastases

NCT02642978 | Unknown DMC

• 1 other identifier: RSRCLM
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of robot-assisted simultaneous resection in selected patients with sigmoid colon cancer or rectal cancer liver metastases, and compared with the traditional open procedure.

Conditions

Colorectal Liver Metastasis

Keywords

minimally invasive surgery; colorectal liver metastasis; robotic surgery; Patients with resectable colorectal liver metastasis

Outcome Measures

Primary Outcomes (1)

• Surgical Complication

  According to Clavein-Dindo complication system to calculate the complication events during 30 day after surgery

  30 days after surgury

Secondary Outcomes (4)

• Operative mortality

  30 days post operatively

• Disease-free survival(DFS)

  3 years disease-free survival

• overall survival (OS)

  OS rate at 3 and 5 years after operation

• locoregional recurrence rate

  3 and 5 years

Other Outcomes (4)

• self reported bladder function

  at postoperative 3, 6 and 1 2 months

• self reported sexual function for male patients

  at postoperative 3, 6 and 1 2 month

• self reported sexual function for female patients

  at postoperative 3, 6 and 1 2 months

Study Arms (2)

RSRCLM

EXPERIMENTAL

robot-assisted, simultaneous radical resection of both colorectal cancer and liver metastasis (RSRCLM).Three different liver resection procedures were chose to personalized patients. Generally, when the size of liver metastasis was ≤ 3 cm, a wedge resection was chose without Hilar vessels blocking. The segmentectomy was performed using the Glissonian approach when tumor size was among 3-5 cm, and Hilar vessels was blocked, if necessary. For resection of Couinaud's segments II and III, left lateral sectionectomy (LLS) was performed commonly. Intraoperative ultrasound can help us find intrahepatic pedicles and follow the proper resection line. When liver tumor size was more than 5 cm or more than 3 tumors with the size over 3cm, hemicolectomy was applied usually.

Procedure: RSRCLM

Open

ACTIVE COMPARATOR

Traditional open simultaneous radical resection of both colorectal cancer and liver metastasis. The DFS and safety event were evaluated.

Procedure: Open

Interventions

RSRCLM PROCEDURE

The Da Vinci Surgical System may help to overcome some of the difficulties of laparoscopy for complicated abdominal surgery. The aim of this study was to present an innovative technique that is robot-assisted, simultaneous radical resection of both colorectal cancer and liver metastasis (RSRCLM).

RSRCLM

Open PROCEDURE

Traditional open simultaneous radical resection of both colorectal cancer and liver metastasis

Open

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and ≤ 75 years;
• Primary tumor has undergone histologically confirmed colon adenocarcinoma; Colon cancer was defined by the presence of the inferior pole of the tumor above the peritoneal reflection (at least 15 cm from the anal margin).
• Together with clinical or radiological evidence of Stage II (T3-4, N0, M0) or Stage III (T1-4, N1-2, M0) disease (according to the 2010 revision of the International Union Against Cancer primary tumor, regional nodes, metastasis (TNM) staging system);Liver metastasis was diagnosis by multidisciplinary (MDT) team base on liver Magnetic Resonance Imaging (MRI) and Positron Emission Computed Tomography (PET-CT).
• Performance status (ECOG) 0\~1
• Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; hemoglobin (Hb) ≥9g/dl (within 1 week prior to randomization)
• Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either primary tumor, regional nodes, metastasis (AST) or ALT) ≤ 5 x ULN(within 1 week prior to randomization);
• Written informed consent for participation in the trial.
• The liver resectability was evaluated by liver surgery of MDT team, indication including: tumor number ≤ 3; the Maximum diameter of one tumor ≤ 10 cm.

You may not qualify if:

• Body mass index (BMI) more than 30 kg/m2.
• Serious pre-operative comorbidity, including cardiovascular disease (coronary arteriosclerosis, arrhythmia, heart failure), pulmonary dysfunction (lung emphysema, obstructive lung disease), liver insufficiency (Child-Pugh B or C), renal insufficiency (serum creatinine \>2.0 mg/dl), and arterial circulation disturbance (occlusion of arterial vessels of limb in patient's history.
• History of accepting abdominal surgery.
• Liver tumor located at I or invasive the middle hepatic vein.

Sponsors & Collaborators

• Xu jianmin: lead

Study Sites (1)

Department of General Surgery, Zhongshan Hospital, Fudan University

Shanghai, 200032, China

RECRUITING

Related Publications (1)

• Chang W, Ye Q, Xu D, Liu Y, Zhou S, Ren L, He G, Zhou G, Liang F, Fan J, Wei Y, Wang X, Xu J. Robotic versus open surgery for simultaneous resection of rectal cancer and liver metastases: a randomized controlled trial. Int J Surg. 2023 Nov 1;109(11):3346-3353. doi: 10.1097/JS9.0000000000000581.

  PMID: 37800563 DERIVED

Study Officials

• wenju chang, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jianmin Xu, MD

CONTACT

008613501984869; xujmin@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Fudan University

Model Details: micro-invasive surgery

Study Record Dates

• First Submitted: September 8, 2015
• First Posted: December 30, 2015
• Study Start: September 1, 2015
• Primary Completion: April 1, 2019
• Study Completion: September 1, 2019
• Last Updated: March 29, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)