The Value of MRI in Assessing the Status of Retroperitoneal Resection Margin in Colon Cancer

Sponsor

Peking University Cancer Hospital & Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT05859581

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this clinical trial is to explore the value of colon MRI in assessing the status of retroperitoneal resection margin (RPRM) for advanced colon cancer.

The main questions it aims to answer are:

Concordance between MRI suspected RPRM positive and pathologically confirmed positive.
Can RPRM-positive patients undergo beyond complete mesocolic excision (CME) surgery in order to achieve R0 resection?

Participants will undergo colon MRI examination and once MRI suspects RPRM positive, they will receive beyond CME surgery.

Condition or Disease	Intervention/Treatment	Phase
Colon Cancer	Procedure: Beyond complete mesocolic excision surgery	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

29 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

To Explore the Value of Colon MRI in Assessing the Status of Retroperitoneal Resection Margin Following Beyond Complete Mesocolic Excision Surgery for Advanced Colon Cancer

Actual Study Start Date :

Apr 2, 2023

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Aug 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Suspected positive RPRM on MRI	Procedure: Beyond complete mesocolic excision surgery If the participants were diagnosed with positive retroperitoneal resection margin (RPRM), they underwent beyond complete mesocolic excision surgery to ensure the R0 resection.

Arm

Intervention/Treatment

Experimental: Suspected positive RPRM on MRI

Procedure: Beyond complete mesocolic excision surgery

If the participants were diagnosed with positive retroperitoneal resection margin (RPRM), they underwent beyond complete mesocolic excision surgery to ensure the R0 resection.

Outcome Measures

Primary Outcome Measures

Coincidence rate with pathological result [within 2 weeks after surgery]
Coincidence rate between MRI diagnosed retroperitoneal resection margin and pathologically confirmed positive

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

primary colon adenocarcinoma confirmed by biopsy
preoperative CT suspecting retroperitoneal resection margin (RPRM) positive
received colon MRI scan
underwent beyond complete mesocolic excision surgery
sufficient clinical and pathological results

Exclusion Criteria:

combined with other malignant tumors
simultaneous distant metastasis
definite invaded other organs or structures (T4b tumors)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Cancer Hospital	Beijing	Beijing	China	100142

Sponsors and Collaborators

Peking University Cancer Hospital & Institute

Investigators

Principal Investigator: Ying-Shi Sun, MD, Peking University Cancer Hospital & Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peking University Cancer Hospital & Institute

ClinicalTrials.gov Identifier:

NCT05859581

Other Study ID Numbers:

Colon MRI-2023-01

First Posted:

May 16, 2023

Last Update Posted:

May 16, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Peking University Cancer Hospital & Institute

Colon cancer

MRI

Resection margin

Additional relevant MeSH terms:

Colonic Neoplasms

Study Results

No Results Posted as of May 16, 2023