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Trial record 24 of 1002 for:    colon cancer AND resection

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

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ClinicalTrials.gov Identifier: NCT02642978
Recruitment Status : Recruiting
First Posted : December 30, 2015
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Xu jianmin, Fudan University

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.

Condition or disease Intervention/treatment Phase
Colorectal Liver Metastasis Procedure: RSRCLM Procedure: Open Not Applicable

Detailed Description:
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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: micro-invasive surgery
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Safety and Effect of Robot-assisted Procedure Versus Open Simultaneous Resection of Colorectal Cancer: Randomized Control Trial Study
Actual Study Start Date : September 1, 2015
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RSRCLM
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
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).

Active Comparator: Open
Traditional open simultaneous radical resection of both colorectal cancer and liver metastasis. The DFS and safety event were evaluated.
Procedure: Open
Traditional open simultaneous radical resection of both colorectal cancer and liver metastasis




Primary Outcome Measures :
  1. Surgical Complication [ Time Frame: 30 days after surgury ]
    According to Clavein-Dindo complication system to calculate the complication events during 30 day after surgery


Secondary Outcome Measures :
  1. Operative mortality [ Time Frame: 30 days post operatively ]
    death occurred 30 days after operation

  2. Disease-free survival(DFS) [ Time Frame: 3 years disease-free survival ]
    DFS was defined as from the date of randomization to the date of tumor

  3. overall survival (OS) [ Time Frame: OS rate at 3 and 5 years after operation ]
    overall survival was defined as from the date of randomization to the date of Death ;

  4. locoregional recurrence rate [ Time Frame: 3 and 5 years ]
    local recurrence rate at 3 and 5 years after operation


Other Outcome Measures:
  1. self reported bladder function [ Time Frame: at postoperative 3, 6 and 1 2 months ]
    This section is assessed using a self-rating scale "International prostate symptom score" (IPSS)

  2. self reported sexual function for male patients [ Time Frame: at postoperative 3, 6 and 1 2 month ]
    This section is assessed using a self-rating scale "International Index of Erectile Function" (IIEF-5).

  3. self reported sexual function for female patients [ Time Frame: at postoperative 3, 6 and 1 2 months ]
    This section is assessed using a self-rating scale "Female Sexual Function Index" (FSFI).

  4. liver function [ Time Frame: at Day 1,3,5 after surgery ]
    Serum aminotransferase will be tested in the laboratory



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 and ≤ 75 years;
  2. 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).
  3. 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).
  4. Performance status (ECOG) 0~1
  5. Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; hemoglobin (Hb) ≥9g/dl (within 1 week prior to randomization)
  6. 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);
  7. Written informed consent for participation in the trial.
  8. The liver resectability was evaluated by liver surgery of MDT team, indication including: tumor number ≤ 3; the Maximum diameter of one tumor ≤ 10 cm.

Exclusion Criteria:

  1. Body mass index (BMI) more than 30 kg/m2.
  2. 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.
  3. History of accepting abdominal surgery.
  4. Liver tumor located at I or invasive the middle hepatic vein.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02642978


Contacts
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Contact: jianmin Xu, MD 008613501984869 xujmin@aliyun.com

Locations
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China
Department of General Surgery, Zhongshan Hospital, Fudan University Recruiting
Shanghai, China, 200032
Contact: jianmin xu, professor    008613501984869    xujmin@yahoo.com.cn   
Contact: yunshi zhong, doctor    008613564623481    zhong780124@sina.com   
Sponsors and Collaborators
Xu jianmin
Investigators
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Principal Investigator: wenju chang, MD Fudan University

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Responsible Party: Xu jianmin, Fudan University
ClinicalTrials.gov Identifier: NCT02642978     History of Changes
Other Study ID Numbers: RSRCLM
First Posted: December 30, 2015    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xu jianmin, Fudan University:
minimally invasive surgery
colorectal liver metastasis
robotic surgery
Patients with resectable colorectal liver metastasis
Additional relevant MeSH terms:
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Neoplasm Metastasis
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases
Liver Extracts
Hematinics