Clinical trial · Interventional
Investigate the Radical Extent of Lymphadenectomy of LAparoscopic Right Colectomy for Colon Cancer(RELARC).
A Multicenter, Prospective, Randomized Clinical Trial to Investigate the Radical Extent of Lymphadenectomy: D2 Dissection vs. Complete Mesocolic Excision, of LAparoscopic Right Colectomy for Right-sided Colon Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Complete mesocolic excision (CME) | Procedure | — | UNRESOLVED |
| D2 radical operation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- D2 radical operation group
- description
- 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.
- interventionNames
- Procedure: D2 radical operation
- type
- EXPERIMENTAL
- label
- CME group
- description
- 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.
- interventionNames
- Procedure: Complete mesocolic excision (CME)
Primary outcomes (1)
- measure
- Disease-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients suitable for curative surgery 18-75years old 2. ASA grade I-III 3. Qualitative diagnosis: a pathological diagnosis of adenocarcinoma; 4. Localization diagnosis: the tumor located between the cecum and the right 1/3 of transverse colon; 5. Enhanced CT scan of chest, abdominal and pelvic cavity: assessment of tumor stage is T2-T4N0 or TanyN+; there is no distant metastasis. 6. Informed consent Exclusion Criteria: 1. Simultaneous or simultaneous multiple primary colorectal cancer; 2. Preoperative imaging examination results show: (1) colon cancer of stage T1N0; (2) enlargement of lymph node at the root of mesocolon, in which case the D3 radical operation must be performed; 3. 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; 4. History of any other malignant tumor in recent 5 years, except for cervical carcinoma in situ which has been cured, basal cell carcinoma or squamous cell carcinoma of skin; 5. Patients need emergency operation; 6. Not suitable for laparoscopic surgery (i.e., extensive adhesion caused by abdominal surgery, not suitable for artificial pneumoperitoneum, etc). 7. Informed consent refusal
References
Publications (5)
- DERIVEDLi 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. PMID 40938728
- DERIVEDLu 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. PMID 39190853
- DERIVEDSun 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. PMID 38773832
- DERIVEDXu 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. PMID 33587893
- DERIVEDLu 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. PMID 27931247