Borderline of CME/D3 Dissection for Local Advanced Right-sided Colon Cancer

NCT ID: NCT06709144

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

896 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2032-06-30

Brief Summary

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The study was conducted on patients with advanced right-sided colon cancer, and the clinical pathological and prognostic data of the patients were compared between the two groups of patients who were randomly divided into those undergoing SMV and SMA left resection, with the aim of resolving the controversy over the left resection boundary of CME/D3 lymph node dissection through this study, and to clarify whether SMA left resection is superior to SMV left resection.

Detailed Description

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Conditions

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Colon Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group SMA

The lymph node dissection boundary is on the left side of the superior mesenteric artery (SMA).

Group Type EXPERIMENTAL

SMA lymph node dissection

Intervention Type PROCEDURE

The lymph node dissection boundary is on the left side of the superior mesenteric artery (SMA)

Group SMV

The lymph node dissection boundary is on the left side of the superior mesenteric vein (SMV)

Group Type ACTIVE_COMPARATOR

SMV lymph node dissection

Intervention Type PROCEDURE

The lymph node dissection boundary is on the left side of the superior mesenteric vein (SMV)

Interventions

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SMA lymph node dissection

The lymph node dissection boundary is on the left side of the superior mesenteric artery (SMA)

Intervention Type PROCEDURE

SMV lymph node dissection

The lymph node dissection boundary is on the left side of the superior mesenteric vein (SMV)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* right side colon cancer(The primary lesion is located in the ileocecal region, ascending colon, hepatic flexure of colon, or proximal transverse colon)
* T3-4 and/or N1-2M0
* Colonoscopy and pathological biopsy confirmed colon adenocarcinoma

Exclusion Criteria

* T1-2N0M0
* Cannot undergo curative resection
* Simultaneous multiple primary colorectal cancer or other diseases requiring segmental resection
* Distant metastasis
* Tumor invades surrounding organs, requiring joint organ resection
* Emergency surgery is required for complications such as intestinal obstruction, perforation, and bleeding
* Patients who have received neoadjuvant therapy before surgery
* Pregnant or lactating women
* Patients who are not suitable or unable to tolerate surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangxi Provincial Cancer Hospital

OTHER

Sponsor Role collaborator

Jiangsu Cancer Institute & Hospital

OTHER

Sponsor Role collaborator

Liaoning Cancer Hospital & Institute

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role collaborator

Shanxi Province Cancer Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Shanxi Medical University

OTHER

Sponsor Role collaborator

Shaoxing People's Hospital

OTHER

Sponsor Role collaborator

Shaoxing Second Hospital

OTHER

Sponsor Role collaborator

Ningbo No. 1 Hospital

OTHER

Sponsor Role collaborator

Ningbo No.2 Hospital

OTHER

Sponsor Role collaborator

Jinhua Central Hospital

OTHER

Sponsor Role collaborator

Affiliated Hospital of Jiaxing University

OTHER

Sponsor Role collaborator

The First People's Hospital of Huzhou

OTHER

Sponsor Role collaborator

The Central Hospital of Lishui City

OTHER

Sponsor Role collaborator

Lishui Country People's Hospital

OTHER

Sponsor Role collaborator

Zhejiang University

OTHER

Sponsor Role collaborator

Yuyao People's Hospital

OTHER

Sponsor Role collaborator

The Third Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

Cancer Hospital of Guangxi Medical University

OTHER

Sponsor Role collaborator

Ningbo Medical Center Lihuili Hospital

OTHER_GOV

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role collaborator

Shanghai Cancer Hospital, China

OTHER

Sponsor Role collaborator

The Affiliated Tumor Hospital of Harbin Medical University

UNKNOWN

Sponsor Role collaborator

Shanghai 10th People's Hospital

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role collaborator

Xiangshan No.1 People' s Hospital

UNKNOWN

Sponsor Role collaborator

Zhejiang Province People's Hospital

UNKNOWN

Sponsor Role collaborator

Sir Run Run Shaw Hospital

OTHER

Sponsor Role collaborator

Sun Yat-sen University Cancer Hosptial

UNKNOWN

Sponsor Role collaborator

Haixing Ju, MD

OTHER

Sponsor Role lead

Responsible Party

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Haixing Ju, MD

Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Haixing Ju

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

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Zhejiang cancer hospital

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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2024IITZA001

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-2024-935(IIT)

Identifier Type: -

Identifier Source: org_study_id