Clinical trial NCT02682589: Open Versus Laparoscopic Complete Mesocolic Excision for Locally Advanced Colon Cancer
Official title: A Multicenter, Prospective, Randomized Clinical Trial to Investigate Open Versus Laparoscopic Complete Mesocolic Excision for Locally Advanced Colon Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colon Cancer
Keywords: Complete Mesocolic Excision
locally advanced Colon Cancer
Laparoscopic
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: West China Hospital
name: Changhai Hospital
name: Chinese PLA General Hospital
name: Peking Union Medical College Hospital
name: Ruijin Hospital
name: RenJi Hospital
name: Shanghai Changzheng Hospital
name: Wuhan Union Hospital, China
name: Fujian Medical University
name: First Affiliated Hospital of Chongqing Medical University
First posted: 2016-02-15
Enrollment: 1080
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized, multicenter, phase III trial to compare the short and long outcomes of laparoscopic CME with open CME in treating patients with locally advanced colon cancer.

Detailed description: Laparoscopic complete mesocolic excision (CME) in treating colon cancer has been reported to be feasible and safe and holds many advantages when compared with traditional open surgery, such as reducing preoperative blood loss, alleviating postoperative pain and reducing complications and length of hospital stay. Whether laparoscopic CME could achieve an equivalent oncological outcome, especially for locally advanced malignancy, is still being discussed.

The purpose of this study is to determine the short and long outcomes of open and laparoscopic CME for locally advanced colon cancer patients. The primary endpoint is the 5-year disease-free survival rate. Secondary endpoints include completeness of mesocolon, morbidity and mortality, local recurrence, overall survival, quality of life et al.

In this study, eligible patient will be randomly allocated to receive either open or laparoscopic CME surgery. Randomization will be performed centrally and be stratified for age, gender, T-stage, tumor location. Patients will be randomized in a 2:1 ratio, in favor of the laparoscopic CME.

The extent of resection according to CME principle is identical for both arms. CME involves the removal of the afflicted colon and its accessory lymphvascular supply at their origins by resecting the colon and mesocolon in an intact envelope of visceral peritoneum and mesenteric fascia. Type of anastomosis, location of auxiliary incision and drainage of surgical field are up to the discretion of the surgeon. In laparoscopic surgery, a "medial-to-lateral" approach and a no-touch isolation are required .

Intraoperative pictures were taken at various stages, as were photographs of the postoperative specimen, which will be assessed by a third-party expert to qualify the surgery.

The baseline demographics and conditions as well as the perioperative and postoperative outcomes will be recorded through a prior designed format.

Our study is expected to last seven years, of which two years for recruiting patients, five years for follow-up. Patients are followed up every 3 months for 2 year, every 6 months for 3 years postoperatively.

Eligibility criteria: Inclusion Criteria:

* Patients suitable for curative surgery over 18 years old;
* American Society of Anesthesiologists(ASA) grade I-III;
* Pathological diagnosis of adenocarcinoma;
* Tumor located between the cecum and sigmoid colon;
* Enhanced CT scan of chest, abdominal and pelvic cavity: preoperative assessment of tumor stage is T3-T4 N0 or T any N+ (according to the National Comprehensive Cancer Network(NCCN) clinical practice guidelines in oncology: colon cancer version 2.2015);there is no distant metastasis;
* Informed consent;
* No preoperative chemoradiotherapy;
* No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.

Exclusion Criteria:

* Pregnant patient;
* History of psychiatric disease;
* Use of systemic steroids;
* Conversion to laparotomy;
* Simultaneous or simultaneous multiple primary colorectal cancer;
* Preoperative imaging examination results show:

  1. Tumor involves the surrounding organs and combined organ resection need to be done;
  2. distant metastasis;
  3. unable to perform R0 resection;
* Postoperative pathology of T1-T2 N0;
* History of any other malignant tumor in recent 5 years;
* Patients need emergency operation: mechanic ileus, perforation.
* Not suitable for laparoscopic surgery (i.e., extensive adhesion caused by abdominal surgery, not suitable for artificial pneumoperitoneum, etc).

Primary outcomes:
measure: disease-free survival
timeFrame: 5 years
Secondary outcomes:
measure: overall survival
timeFrame: 5 years
measure: recurrence-free survival
timeFrame: 5 years
measure: local recurrence rate
timeFrame: 5 years
measure: length of postoperative hospital stay
timeFrame: 30 days
measure: early complication rate
timeFrame: 30 days
measure: operative time
timeFrame: 1 day
measure: completeness of the mesocolon of the specimen
timeFrame: 1 day
measure: number of lymph nodes retrieved
timeFrame: 1 day
measure: postoperative quality of life as assessed by EORTC QLQ-C30 questionnaire
timeFrame: 5 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu province hospital
state: Jiangsu
Study officials:
affiliation: Ethics Committee of the First Affiliated Hospital, Nanjing Medical University, Jiangsu Province Hospital
name: Fumin Zhang, Professor
role: STUDY_DIRECTOR
References: