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Cola

The surgeon will be involved into the Japanese pathological investigation method. The surgeon will perform the intraoperative markings and the postoperative lymph node harvest, after which the specimen will be assessed by the pathologist.

After receiving the resected specimen, the entire process will be independently managed by the pathologist.

Japanese pathological investigation

The 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.

European pathological investigation

Mingze He

Vladimir Balaban

Petr Tsarkov

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.

CompariSon Between the EuroPeAn and Japanese pathologiCal InvEstigation for Colon Cancer (SPACE)

Comparison Between the European and Japanese Pathological Investigation for Colon Cancer (SPACE)

indentification of the rate of postive lymph nodes

indentification of the rate of postive lymph nodes using immunohistochemical examination

LNR=Postivie lymph node/ Total retrived lymph node

indentification of the rate of the pathological T stages

indentification of the rate of the postive proximal, distal or circular resection margin

indentification of the rate of tumor budding

indentification of the rate of the tumor-infiltrating lymphocytes (TIL) count

indentification of the rate of the extracapsular invasion

indentification of the rate of the venous, lymphatic or perineural extramural invasion

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CompariSon Between the EuroPeAn and Japanese pathologiCal InvEstigation for Colon Cancer (SPACE)	NCT06119867	Colonic Neoplas...	Japanese pathol... European pathol...	-	Russian Society of Colorectal Surgeons
CompariSon Between the EuroPeAn and Japanese pathologiCal InvEstigation for Colon Cancer (SPACE)	NCT06119867	Colonic Neoplas...	Japanese pathol... European pathol...	-	Russian Society of Colorectal Surgeons
CompariSon Between the EuroPeAn and Japanese pathologiCal InvEstigation for Colon Cancer (SPACE)	NCT06119867	Colonic Neoplas...	Japanese pathol... European pathol...	-	Russian Society of Colorectal Surgeons

Spots Global Cancer Trial Database for european pathological investigation