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Trial record 43 of 998 for:    colon cancer AND resection

Open Versus Laparoscopic Complete Mesocolic Excision for Locally Advanced Colon Cancer (OLCMECC)

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ClinicalTrials.gov Identifier: NCT02682589
Recruitment Status : Recruiting
First Posted : February 15, 2016
Last Update Posted : July 6, 2016
Sponsor:
Collaborators:
West China Hospital
Changhai Hospital
Chinese PLA General Hospital
Peking Union Medical College Hospital
Ruijin Hospital
RenJi Hospital
Shanghai Changzheng Hospital
Wuhan Union Hospital, China
Fujian Medical University
First Affiliated Hospital of Chongqing Medical University
Information provided by (Responsible Party):
Yueming Sun, The First Affiliated Hospital with Nanjing Medical University

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.

Condition or disease Intervention/treatment Phase
Colon Cancer Procedure: Open surgery Procedure: Laparoscopic surgery Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1080 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Prospective, Randomized Clinical Trial to Investigate Open Versus Laparoscopic Complete Mesocolic Excision for Locally Advanced Colon Cancer
Study Start Date : April 2016
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Arm Intervention/treatment
Active Comparator: Open surgery
Patients undergo open CME. A standard midline incision carefully protected is made through the abdominal wall and the abdominal cavity is explored. A colectomy with CME is performed with the removal of the afflicted colon and its accessory lymphovascular supply at their origins by resecting the colon and mesocolon in an intact envelope of visceral peritoneum and mesenteric fascia.
Procedure: Open surgery
A traditional midline incision is made through the abdominal wall and a colectomy with CME is performed.

Experimental: Laparoscopic surgery
Patients undergo laparoscopic CME. A small infraumbilical incision is made through the abdominal skin and the abdominal cavity is insufflated with carbon dioxide to allow access and visualization. The abdominal cavity is explored. A colectomy with CME is performed using laparoscopic-assisted techniques. A 6-8cm midline auxiliary incision is made for specimen extraction and anastomosis.
Procedure: Laparoscopic surgery
3-5 small incisions are made through the abdominal wall for the placement of trocars and the abdominal cavity is insufflated with carbon dioxide to allow access, visualization and operation. A 6-8cm auxiliary incision is made for specimen extraction and anastomosis. Conversion may occur due to technical difficulties or intraoperative complications, which is defined when completion of the dissection of the mesocolon is performed through a traditional open abdominal approach. Patients undergo conversion to laparotomy will be excluded from this study.




Primary Outcome Measures :
  1. disease-free survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 5 years ]
  2. recurrence-free survival [ Time Frame: 5 years ]
  3. local recurrence rate [ Time Frame: 5 years ]
  4. length of postoperative hospital stay [ Time Frame: 30 days ]
    Length of postoperative hospital stay is defined as a duration between surgery and first discharge. An expected average is 10 days.

  5. early complication rate [ Time Frame: 30 days ]
    Early complication is defined as a complication that occurred between the finish of the surgery and postoperative day 30. Complications includes anastomotic leakage, anastomotic bleeding, chyle leakage, wound infection, pulmonary embolism, myocardial infarction et al.The Clavien-Dindo Classification of Surgical Complications will be applied to access the degree of severity of postoperative complications.

  6. operative time [ Time Frame: 1 day ]
  7. completeness of the mesocolon of the specimen [ Time Frame: 1 day ]
    A central review by pathologists to define the completeness of the mesocolon to be good, moderate or poor will be performed on the specimen photographs.

  8. number of lymph nodes retrieved [ Time Frame: 1 day ]
  9. postoperative quality of life as assessed by EORTC QLQ-C30 questionnaire [ Time Frame: 5 years ]
    Compare the differences in postoperative quality of life of patients treated with these two regimens using EORTC QLQ-C30 questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

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): NCT02682589


Contacts
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Contact: Yueming Sun, PhD 02568136026 jssym@vip.sina.com

Locations
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China, Jiangsu
Jiangsu province hospital Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Yueming Sun    68136026    jssym@vip.sina.com   
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
West China Hospital
Changhai Hospital
Chinese PLA General Hospital
Peking Union Medical College Hospital
Ruijin Hospital
RenJi Hospital
Shanghai Changzheng Hospital
Wuhan Union Hospital, China
Fujian Medical University
First Affiliated Hospital of Chongqing Medical University
Investigators
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Study Director: Fumin Zhang, Professor Ethics Committee of the First Affiliated Hospital, Nanjing Medical University, Jiangsu Province Hospital

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Responsible Party: Yueming Sun, Director of the Colorectal Surgery Department, The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT02682589     History of Changes
Other Study ID Numbers: CRSYM201602
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Yueming Sun, The First Affiliated Hospital with Nanjing Medical University:
Complete Mesocolic Excision
locally advanced Colon Cancer
Laparoscopic
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases