NCT03826862

Brief Summary

The investigators will perform CT three-dimension reconstruction for middle-low rectal cancer patients who have enlarged lateral lymph nodes to recognize the variance of pelvic vessels, by which to help reduce operative time and blood loss, localize the lateral lymph nodes, improve the lymph node harvested and positive rate. Besides, The investigators will label the vessels near the interested node to achieve node-by-node for further investigation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

2.3 years

First QC Date

January 25, 2019

Last Update Submit

January 30, 2019

Conditions

Rectal Cancer

Keywords

lateral lymph node dissectionnode-by-noderectal cancerCT three-dimensional reconstructioninternal iliac vessels dissection

Outcome Measures

Primary Outcomes (7)

  • operative time

    including total operative time and that for lateral lymph node

    2 year

  • Blood loss

    intraoperative blood loss

    2 year

  • lateral lymph node harvested

    lateral lymph node harvested

    2 year

  • Accuracy of judgement for lateral lymph node metastasis

    including radiologists' and surgeons' accuracy

    2 year

  • Cut-off value of shorter diameter

    The best cut-off value of shorter diameter for lateral lymph node dissection

    2 year

  • vessels variances

    The blood vessels variance of internal iliac vessels

    October 1. 2018-December 31.2020

  • postoperative complication

    including urinary and sexual function

    2 year

Secondary Outcomes (3)

  • local recurrence rate

    3 year

  • overall survival

    3 year

  • disease-free survival

    3 year

Study Arms (2)

intervention group

EXPERIMENTAL

All patients receive CT three-dimensional reconstruction before surgery.

Radiation: CT three-dimensional reconstruction

control group

NO INTERVENTION

All patients did not receive CT three-dimensional before surgery

Interventions

CT three-dimensional reconstructionRADIATION

All patients will receive CT three dimensional reconstruction before surgery

intervention group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Ziqiang Wang, MD

    Department of Gastrointestinal Surgery, West China Hospital, Sichuan University

    STUDY CHAIR

Central Study Contacts

Ziqiang Wang, MD

CONTACT

+8618980602028xbzhang262402@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This group with intervention will be compared previous group without intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

January 25, 2019

First Posted

February 1, 2019

Study Start

October 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 30, 2022

Last Updated

February 1, 2019

Record last verified: 2019-01

Locations

CN(1)