NCT04848311

Brief Summary

This is a prospective randomized controlled study. investigators will randomly assign patients to the indocanine green (ICG) group and control (CL)group to compare the differences of lymph nodes dissection in station 253 between the two groups.

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
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

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

First Submitted

Initial submission to the registry

April 12, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 19, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

April 19, 2021

Status Verified

December 1, 2020

Enrollment Period

1 year

First QC Date

April 12, 2021

Last Update Submit

April 16, 2021

Conditions

Rectal CarcinomaSigmoid Colon Carcinoma

Keywords

ICG253 lymph nodesrectal carcinomasigmoid colon carcinoma

Outcome Measures

Primary Outcomes (1)

  • number of harvested station 253 lymph nodes

    number of harvested station 253 lymph nodes,number of positive station 253 lymph nodes,rate of positive station 253 lymph nodes

    one week after operation

Secondary Outcomes (3)

  • number of harvested station 251 lymph nodes

    one week after operation

  • number of harvested station 252 lymph nodes

    one week after operation

  • number of total lymph nodes harvested

    one week after operation

Other Outcomes (4)

  • operative time

    intraoperative

  • post-operative data

    one hour after operation

  • post-operative hospital stay

    two weeks after operation

  • +1 more other outcomes

Study Arms (2)

ICG group

EXPERIMENTAL

Patients in the ICG group will undergo endoscopic injection of ICG 4 hours before surgery. The ICG powder will be dissolved in 2.5mg/ml of sterile water. ICG will be injected along the submucosa at 4 points around the primary tumor,for a total volume of 10ml.

Procedure: lymph nodes dissection at 253 station assisted by ICG

CLgroup

NO INTERVENTION

Patients in the CL group will undergo routine laparoscopic lymph nodes dissection instead of using any tracer.

Interventions

lymph nodes dissection at 253 station assisted by ICGPROCEDURE

In ICG group :All patients will be subjected to laparoscopic radical resection with station 253 lymph nodes dissection by fluorescence laparoscopic.

ICG group

Eligibility Criteria

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

You may qualify if:

  • (1)18-80 years of age (2)American Society of Anesthesiologists (ASA) class 1-3 (3)single rectal or sigmoid colon carcinoma confirmed pathologically by endoscopic biopsy (4)planned laparoscopic radical resection (5)Written informed consent

You may not qualify if:

  • previous abdominal tumor surgery
  • women who are pregnant or breast feeding
  • emergency patients with obstruction or perforation
  • T4b cancer evaluated by CT or MRI or endoscopic ultrasonography
  • pelvic or distant metastasis
  • T1 cancer planned local excision
  • allergic constitution patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (1)

  • Wan J, Wang S, Yan B, Tang Y, Zheng J, Ji H, Hu Y, Zhuang B, Deng H, Yan J. Indocyanine green for radical lymph node dissection in patients with sigmoid and rectal cancer: randomized clinical trial. BJS Open. 2022 Nov 2;6(6):zrac151. doi: 10.1093/bjsopen/zrac151.

    PMID: 36515673DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jun Yan, M.D,Ph.D

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Yan, M.D,Ph.D

CONTACT

13825066546yanjunfudan@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2021

First Posted

April 19, 2021

Study Start

May 1, 2021

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

April 19, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)