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| Name | Class |
|---|---|
| Chinese PLA General Hospital | OTHER |
| Sixth Affiliated Hospital, Sun Yat-sen University | OTHER |
| Peking University Cancer Hospital & Institute | OTHER |
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To investigate whether extended lymphadenectomy (CME) in laparoscopic colectomy could improve disease-free survival in patients with right colon cancer, compared with standard D2 radical operation.
Our study design is a two-arm, parallel-group, single-blind randomized clinical trial. The enrolled colon cancer patients would be divided into the intervention group (CME group) and control group (D2 radical operation group).
The postoperative adjuvant chemotherapy is determined by the pathological results. For patients of stage â…¢ and patients of stage â…¡ with unfavorable histologic features, six months of adjuvant chemotherapy of XELOX or fluorouracil-based regimen are recommended.
The postoperative examination should be performed every four months in the first two years and every six months in the following three years, to exclude local recurrence and distant metastasis.
Our study is expected to last five years, of which two years for recruiting patients, three years for follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D2 radical operation group | Active Comparator | In D2 radical operation group(D2), the mesocolon should be removed and the dissection involves the paracolon and intermediate lymph nodes, which along the feeding vessels. |
|
| CME group | Experimental | In complete mesocolic excision group (CME), in addition to D2 dissection, the whole mesocolon, from ascending colon to right half transverse colon, as well as the central lymph nodesmshould be entirely removed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D2 radical operation | Procedure | In D2 radical operation group(D2), 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | The proportion of patients with no disease recurrence and metastasis after 3 years of surgery | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications | Complications occurring within 30 days after surgery | 30 days |
| Postoperative mortality | Death occurred within 30 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yi XIAO, MD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lai XU | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40938728 | Derived | Li K, Li H, Wu A, Zang L, Zhang G, Xu L, Lu J, Xing J, Feng B, Sun Y, Du X, Chi P, Xu J, Wang Z, Zhang Y, Zhang Z, Zheng M, Su X, Xiao Y; RELARC Study Group. Long-Term Survival on Extent of Lymphadenectomy for Right-Sided Colon Cancer: Five-Year Follow-up Results of a Randomized Controlled Trial (RELARC Trial). Ann Surg. 2025 Sep 12. doi: 10.1097/SLA.0000000000006941. Online ahead of print. | |
| 39190853 |
| Label | URL |
|---|---|
| The Radical Extent of lymphadenectomy D2 dissection versus complete mesocolic excision of LAparoscopic Right Colectomy for right-sided colon cancer (RELARC) trial: study protocol for a randomized controlled tria | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| Beijing Friendship Hospital |
| OTHER |
| Xuanwu Hospital, Beijing | OTHER |
| Ruijin Hospital | OTHER |
| Shanghai Zhongshan Hospital | OTHER |
| The First Hospital of Jilin University | OTHER |
| Nanfang Hospital, Southern Medical University | OTHER |
| Fujian Medical University Union Hospital | OTHER |
| Peking Union Medical College | OTHER |
| Peking University People's Hospital | OTHER |
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| First Affiliated Hospital of Harbin Medical University | OTHER |
| RenJi Hospital | OTHER |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER |
| West China Hospital | OTHER |
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| Complete mesocolic excision (CME) | Procedure | 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. |
|
| 30 days |
| 3 years overall survival | The proportion of patients who survived 3 years after surgery | 3 years |
| Metastasis rate of central lymph node (3rd station) | Metastasis rate of central lymph node (3rd station) | 7 days |
| Derived |
| Lu J, Xing J, Zang L, Zhang C, Xu L, Zhang G, He Z, Sun Y, Feng Y, Du X, Hu S, Chi P, Huang Y, Wang Z, Zhong M, Wu A, Zhu A, Li F, Xu J, Kang L, Suo J, Deng H, Ye Y, Ding K, Xu T, Zhang Y, Zhang Z, Zheng M, Su X, Xiao Y; RELARC study group. Extent of Lymphadenectomy for Surgical Management of Right-Sided Colon Cancer: The Randomized Phase III RELARC Trial. J Clin Oncol. 2024 Nov 20;42(33):3957-3966. doi: 10.1200/JCO.24.00393. Epub 2024 Aug 27. |
| 38773832 | Derived | Sun Z, Zhang G, Lu J, Wu B, Lin G, Xiao Y, Xu L. Risk Factors for Postoperative Complications of Laparoscopic Right Colectomy: A Post Hoc Analysis of the RELARC Trial. Dis Colon Rectum. 2024 Sep 1;67(9):1194-1200. doi: 10.1097/DCR.0000000000003331. Epub 2024 May 21. |
| 33587893 | Derived | Xu L, Su X, He Z, Zhang C, Lu J, Zhang G, Sun Y, Du X, Chi P, Wang Z, Zhong M, Wu A, Zhu A, Li F, Xu J, Kang L, Suo J, Deng H, Ye Y, Ding K, Xu T, Zhang Z, Zheng M, Xiao Y; RELARC Study Group. Short-term outcomes of complete mesocolic excision versus D2 dissection in patients undergoing laparoscopic colectomy for right colon cancer (RELARC): a randomised, controlled, phase 3, superiority trial. Lancet Oncol. 2021 Mar;22(3):391-401. doi: 10.1016/S1470-2045(20)30685-9. Epub 2021 Feb 12. |
| 27931247 | Derived | Lu JY, Xu L, Xue HD, Zhou WX, Xu T, Qiu HZ, Wu B, Lin GL, Xiao Y. The Radical Extent of lymphadenectomy - D2 dissection versus complete mesocolic excision of LAparoscopic Right Colectomy for right-sided colon cancer (RELARC) trial: study protocol for a randomized controlled trial. Trials. 2016 Dec 8;17(1):582. doi: 10.1186/s13063-016-1710-9. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |