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The main objective of this study was to evaluate the effect of surgical margin width on the prognosis of patients with hepatic oligometastasis of colorectal cancer by statistical 1-year intrahepatic recurrence-free survival rate (ihRFSrate). The secondary objective of the study was to evaluate the effect of surgical margin width on long-term survival and total recurrence of colorectal cancer in patients with hepatohepatic metastasis by statistical overall survival time (OS) and relapse-free survival time (RFS), and to evaluate the safety of wide margin surgery compared with narrow margin surgery in patients with Cromitis during perioperative period.
This was a single-center, prospective, randomized controlled clinical study to evaluate the effects of surgical margin width on 1-year intrahepatic relapse-free survival, relapse-free survival time, overall survival time, and perioperative safety in patients with hepatic oligometastasis of colorectal cancer. Subjects will undergo radical resection of liver tumors and will be randomly assigned to a wide margin group (≥7mm) or narrow margin group (<7mm) using stratified randomization, stratified by primary lesion site (right colon vs left colon/rectum). The margin width was the narrowest margin distance measured in fresh specimens. After radical liver tumor resection, subjects were pretreated regularly Follow-up evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | The surgical margin width was greater than or equal to 7mm |
|
| Control group | Experimental | The surgical margin width was less than 7mm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery and procedure | Procedure | According to the "Chinese Guidelines for the Diagnosis and Comprehensive Treatment of Liver metastases of Colorectal Cancer (2023 edition)", R0 resection of metastatic tumors is satisfied, and the objective is to preserve sufficient functional liver tissue, and the surgical margin width is less than 7mm |
| Measure | Description | Time Frame |
|---|---|---|
| Intrahepatic recurrence-free survival at 1 year(ihRFS rate) | Refers to the percentage of subjects in this group who received intrahepatic imaging diagnosis of recurrence or death from any cause from surgery to 1 year after surgery. | From liver tumor resection to 1 year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence free survival time(RFS) | The earliest date from the date of receipt of liver tumor resection to the date of confirmation of tumor recurrence or the date of death from any cause. Regular follow-up visits were conducted until the end of the study follow-up | 12 months |
| Overall survival time(OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lu Wang, PhD | Contact | +8613601678615 | w.lr@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200062 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21423255 | Result | Weichselbaum RR, Hellman S. Oligometastases revisited. Nat Rev Clin Oncol. 2011 Jun;8(6):378-82. doi: 10.1038/nrclinonc.2011.44. Epub 2011 Mar 22. | |
| 36846977 | Result | Su YM, Liu W, Yan XL, Wang LJ, Liu M, Wang HW, Jin KM, Bao Q, Wang K, Li J, Xu D, Xing BC. Five-year survival post hepatectomy for colorectal liver metastases in a real-world Chinese cohort: Recurrence patterns and prediction for potential cure. Cancer Med. 2023 Apr;12(8):9559-9569. doi: 10.1002/cam4.5732. Epub 2023 Feb 27. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D012008 | Recurrence |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009385 | Neoplastic Processes |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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|
| Surgery and procedure | Procedure | Combined with intraoperative B-ultrasound guidance, 3D reconstruction and intraoperative navigation, the surgical margin width of metastatic tumor was greater than or equal to 7mm |
|
Refers to the time from liver tumor resection to death from any cause, if the above criteria were not met, the date of the last evaluation was used for analysis. |
| 24 months |
| Perioperative safety | In this study, the incidence of perioperative complications was calculated according to Clavien Dindo complication scoring system. At the same time, perioperative death, operative time, intraoperative blood loss, blood transfusion and other surgical safety treatment were counted | Patient 90 days after hepatectomy |
| 38549003 | Result | Laroche S, Scatton O, Charlotte F, Bachet JB, Lim C, Fuks D, Goumard C. Prognosis of a Heterogeneous TRG Pathological Response to Neoadjuvant Chemotherapy in Patients who Undergo Resection for Colorectal Liver Metastases. Ann Surg Oncol. 2024 Jul;31(7):4436-4444. doi: 10.1245/s10434-024-15196-x. Epub 2024 Mar 28. |
| 31908301 | Result | Guckenberger M, Lievens Y, Bouma AB, Collette L, Dekker A, deSouza NM, Dingemans AC, Fournier B, Hurkmans C, Lecouvet FE, Meattini I, Mendez Romero A, Ricardi U, Russell NS, Schanne DH, Scorsetti M, Tombal B, Verellen D, Verfaillie C, Ost P. Characterisation and classification of oligometastatic disease: a European Society for Radiotherapy and Oncology and European Organisation for Research and Treatment of Cancer consensus recommendation. Lancet Oncol. 2020 Jan;21(1):e18-e28. doi: 10.1016/S1470-2045(19)30718-1. |