Japanese observational study to evaluate the accuracy of preoperative imaging diagnosis for lateral pelvic lymph node metastasis in rectal cancer (JCOG1410-A, JUPITER study)

Japanese observational study to evaluate the accuracy of preoperative imaging diagnosis for lateral pelvic lymph node metastasis in rectal cancer (JCOG1410-A, JUPITER study) - Japanese observational study to evaluate the accuracy of preoperative imaging diagnosis for lateral pelvic lymph node metastasis in rectal cancer (JCOG1410-A, JUPITER study)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000016909

Enrollment

550

Registered

2015-03-25

Start date

2015-03-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal cancer with rectal resection and lateral pelvic lymph node dissection

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Adenocarcinoma or adenosquamous carcinoma is pathologically diagnosed by preoperative biopsy. 2) Pelvic enhanced CT and MRI are performed for preoperative imaging (CT data of 1 mm/1.25 mm-thickness and 5 mm-thickness slices, and MRI data of 3 mm-thickness slices are required). 3) Satisfying either of the following criteria: the main tumor part is located either in the lower rectum or anal canal, or the lower edge of the tumor is located in the lower rectum. <1> The tumor invasion depth is deeper than T2. <2> Lateral pelvic lymph node metastasis is suspected by preoperative imaging. <3> Lymph node metastasis in the mesorectum is suspected by preoperative imaging. 4) Chemotherapy and radiotherapy to the rectal cancer is not performed before the operation, and lateral pelvic lymph node dissection is planned simultaneously with rectal resection. 5) There is no past history of operation, chemotherapy, and radiotherapy to intrapelvic tumors (rectal cancer, gynecologic cancer, urologic cancer, etc.). 6) There is no finding of distant organ metastasis, distant lymph node metastasis, and peritoneal dissemination in the preoperative imaging studies (except for cStage IV).

Exclusion criteria

Exclusion criteria: No exclusion criteria

Design outcomes

Primary

Measure	Time frame
False discovery rate (C/C+D)* regarding the diagnosis of lateral pelvic lymph node metastasis. (*: see below colum)	—

Secondary

Measure	Time frame
<1>False omission rate (B/A+B), positive predictive value (D/C+D), negative predictive value (A/A+B), sensitivity (D/B+D), and specificity (A/A+C) regarding the diagnosis of lateral pelvic lymph node metastasis. <2> False discovery rate (C/C+D), false omission rate (B/A+B), positive predictive value (D/C+D), negative predictive value (A/A+B), sensitivity (D/B+D), and specificity (A/A+C) regarding the diagnosis of lateral pelvic lymph node metastasis when adjusted for one or more patient and tumor factors (including gender, histological tumor type, invasion depth, lymph node metastasis in the mesorectum, and distance from the lower edge of the tumor to the anal verge, which were all determined as factors associated with lateral pelvic lymph node metastasis) and the size of the minor axis of the lateral pelvic lymph node in the imaging studies. <3> The differences between the central review result and the imaging diagnosis of each institution. A=preoperatively negative & pathologically negative B= preoperatively negative & pathologically positive C= preoperatively positive & pathologically negative D= preoperatively positive& pathologically positive	—

Measure

Time frame

<1>False omission rate (B/A+B), positive predictive value (D/C+D), negative predictive value (A/A+B), sensitivity (D/B+D), and specificity (A/A+C) regarding the diagnosis of lateral pelvic lymph node metastasis. <2> False discovery rate (C/C+D), false omission rate (B/A+B), positive predictive value (D/C+D), negative predictive value (A/A+B), sensitivity (D/B+D), and specificity (A/A+C) regarding the diagnosis of lateral pelvic lymph node metastasis when adjusted for one or more patient and tumor factors (including gender, histological tumor type, invasion depth, lymph node metastasis in the mesorectum, and distance from the lower edge of the tumor to the anal verge, which were all determined as factors associated with lateral pelvic lymph node metastasis) and the size of the minor axis of the lateral pelvic lymph node in the imaging studies. <3> The differences between the central review result and the imaging diagnosis of each institution. A=preoperatively negative & pathologically negative B= preoperatively negative & pathologically positive C= preoperatively positive & pathologically negative D= preoperatively positive& pathologically positive

—

Countries

Japan

Contacts

Public ContactSatoshi Ikeda

JCOG1410-A Coordinating Office Department of gastroenterology, Hiroshima Prefectural Hospital

JCOG_sir@ml.jcog.jp082-254-1818

Outcome results