About this trial
In general, the European pathological examination method primarily relies on pathologists and does not require the involvement of surgeons. The Japanese pathological evaluation approach, on the other hand, involves the intervention of surgeons, particularly in the extraction of lymph nodes from fresh specimens and the assessment of specimen quality. Given that the Japanese pathological assessment method lacks systematic evaluation and there is currently no literature clearly demonstrating its diagnostic accuracy, the main objective of this study is to verify whether the diagnostic accuracy of the Japanese pathological investigation method is inferior to that of the European pathological evaluation method.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with colon cancer who underwent colectomy;
Patients with pathological confirmed adenocarcinoma;
Patients agreed to participate in the study.
Disqualifiers
Patients suffered from rectal cancer;
Patients diagnosed with colon cancer but did not undergo colectomy;
Patients refused participation.
Trial design
Parallel
Treatments tested in this trial
Japanese pathological investigation
Procedure/SurgeryJapanese pathological investigation
European pathological investigation
Procedure/SurgeryThe European pathology evaluation method involves the analysis of fresh and intact specimens. Pathologists carefully inspect the entire specimen's appearance and assess the surgical resection plane and capture complete photographs for documentation purposes before further sectioning the specimen. During specimen processing, the CRM is initially marked with ink or other markers. After fixation, macroscopic data are recorded, and the entire length of the intestine is cut into cross-sections at intervals of 3-4 millimeters. These sections are then undergoing subsequent systematic pathological examination. However, the surgeon will be involved in the Japanese pathological investigation method. Intraoperative markings will be made 10 cm bilaterally from the primary tumor area. The resected colon will be incised at 1 cm intervals, after which the pericolic lymph nodes will be harvested. Each single retrieved lymph node will be packed up independently and will be examined by the pathologist.
Treatment groups
Trial outcomes
Primary outcomes
Comparision of the incidence of stage III colon cancer between European and Japanese pathological investigation methods.
indentification of the rate of postive lymph nodes
Secondary outcomes
The role of immunohistochemical examination in the Node (N) stage determination
indentification of the rate of postive lymph nodes using immunohistochemical examination
Comparison of the lymph node ratio (LNR) between the European and Japanese pathological approaches
LNR=Postivie lymph node/ Total retrived lymph node
Comparison of the pT Stage between the European and Japanese pathological approaches
indentification of the rate of the pathological T stages
Comparison of the resection margin (proximal, distal, circular) between the European and Japanese pathological approaches
indentification of the rate of the postive proximal, distal or circular resection margin
Sponsors and contacts
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