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Standardization of Laparoscopic Surgery for Right Hemi Colon Cancer (SLRC)

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ClinicalTrials.gov Identifier: NCT02942238
Recruitment Status : Not yet recruiting
First Posted : October 24, 2016
Last Update Posted : December 21, 2016
Sponsor:
Collaborators:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
RenJi Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Fudan University
Information provided by (Responsible Party):
Minhua Zheng, Ruijin Hospital

Brief Summary:
To standardize the surgery for advanced right hemi colon cancer with laparoscopy and investigate whether extended lymphadenectomy (CME) could improve disease-free survival in patients with right colon cancer, compared with D3 radical operation in laparoscopic colectomy.

Condition or disease Intervention/treatment Phase
Overall Survival Postoperative Complications Metastasis Stage, Colon Cancer Procedure: CME Procedure: D3 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 582 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Standardization of Laparoscopic Surgery for Right Hemi Colon Cancer (SLRC)
Study Start Date : January 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: Complete Mesocolic Excision
the group underwent laparoscopic right hemicolectomy with CME. In complete mesocolic excision group (CME), the dissecting extent includes the lymphatic and fat tissues surrounding the root of ascending mesocolon, which situated on the surface of superior mesenteric vein, and the root of right half of transverse mesocolon, which situated on the surface of pancreas neck.
Procedure: CME

the group underwent laparoscopic right hemicolectomy with CME. In CME group, in addition to D2 dissection, the whole mesocolon, from ascending colon to right half transverse colon, as well as the central lymph nodes should be entirely removed.

Intervention: Procedure: Complete mesocolic excision (CME)


Active Comparator: D3 lymph node dissection
the group underwent laparoscopic right hemicolectomy with D3 lymph node dissection. In D3 lymph node dissection group(D3), the lymph node dissection is based on ligating the supplying vessels close to the right-side of superior mesenteric vein and clean up the surrounding lymph node and adipose tissue. No.6 lymph node should be dissected in this group.
Procedure: D3

the group underwent laparoscopic right hemicolectomy with D3 lymph node dissection. In D3 group, the mesocolon should be removed and the dissection involves the paracolon and intermediate lymph nodes,including No.6 lymph node, which along the feeding vessels.

Intervention: Procedure: D3 radical operation





Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. The rate of postoperative complications and mortality [ Time Frame: 30 days ]
  2. 3 years overall survival [ Time Frame: 3 years ]
  3. The rate of local and distant recurrence [ Time Frame: 3 years ]
  4. The accuracy of preoperative staging with CT [ Time Frame: 14 days ]


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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. Patients suitable for curative surgery 18-75years old
  2. Qualitative diagnosis: a pathological diagnosis of adenocarcinoma;
  3. Localization diagnosis: the tumor located between the cecum and the right 1/3 of transverse colon;
  4. Enhanced CT scan of chest, abdominal and pelvic cavity: assessment of tumor stage is T stage 1-4 and N stage 0-2; there is no distant metastasis.
  5. Informed consent

Exclusion Criteria:

  1. Simultaneous or simultaneous multiple primary colorectal cancer;
  2. 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;
  3. History of any other malignant tumor in recent 5 years;
  4. Patients need emergency operation;
  5. Not suitable for laparoscopic surgery;
  6. Women during Pregnancy or breast feeding period;
  7. Informed consent refusal

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): NCT02942238


Contacts
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Contact: Minhua Zheng, PhD +86-13564119545 zmhtiger@yeah.net
Contact: Hiju Hong, PhD Student +86-13564119545 jing12722@naver.com

Sponsors and Collaborators
Ruijin Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
RenJi Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Fudan University
Investigators
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Study Director: Minhua Zheng, PhD Ruijin Hospital

Publications of Results:

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Responsible Party: Minhua Zheng, professor, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT02942238     History of Changes
Other Study ID Numbers: Ruijin-0002
First Posted: October 24, 2016    Key Record Dates
Last Update Posted: December 21, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Minhua Zheng, Ruijin Hospital:
CME
Right hemi Colon cancer
D3
laparoscopy
Additional relevant MeSH terms:
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Colonic Neoplasms
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Postoperative Complications
Pathologic Processes