Standardization of Laparoscopic Surgery for Right Hemi Colon Cancer (SLRC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02942238|
Recruitment Status : Not yet recruiting
First Posted : October 24, 2016
Last Update Posted : December 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Overall Survival Postoperative Complications Metastasis Stage, Colon Cancer||Procedure: CME Procedure: D3||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||582 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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.
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.
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
- Disease-free survival [ Time Frame: 3 years ]
- The rate of postoperative complications and mortality [ Time Frame: 30 days ]
- 3 years overall survival [ Time Frame: 3 years ]
- The rate of local and distant recurrence [ Time Frame: 3 years ]
- The accuracy of preoperative staging with CT [ Time Frame: 14 days ]
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
|Contact: Minhua Zheng, PhDemail@example.com|
|Contact: Hiju Hong, PhD Studentfirstname.lastname@example.org|
|Study Director:||Minhua Zheng, PhD||Ruijin Hospital|