NCT04012645

Brief Summary

It is a multicenter, prospective, and randomized controlled clinical study of patients with mid- or low- rectal cancer who received laparoscopic TME surgery aims to explore whether the application of near infrared-indocyanine green imaging system can evaluate the anastomotic blood perfusion accurately, and optimize the surgical procedures, or even reduce the incidence rates of postoperative anastomotic leakage in mid- or low- rectal cancer patients.

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
547

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

July 6, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
4.4 years until next milestone

Study Start

First participant enrolled

November 16, 2023

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

15 days

First QC Date

July 6, 2019

Last Update Submit

November 15, 2023

Conditions

Rectal Neoplasms

Keywords

Rectal NeoplasmsIndocyanine GreenAnastomotic Leakage

Outcome Measures

Primary Outcomes (1)

  • Anastomotic leakage

    Anastomotic leakage occured within 30 days after operation. The diagnostic criteria for AL include: Flow of gas, abscess, or excrement from pelvic drainage tube, surgical incision or vagina; Accompanied by fever, peritonitis and other systemic symptoms; And AL confirmed by digestive tract radiography, CT scan or enteroscopy.

    within 30 days after operation

Secondary Outcomes (1)

  • the change of surgical precedure

    within the operation time

Study Arms (2)

experimental group

EXPERIMENTAL

Underwent laparoscopic TME and colon-rectum or colon-anal anastomosis. near infrared-indocyanine green imaging system was used during the surgeries.

Procedure: application of near infrared-indocyanine green imaging system

control group

ACTIVE COMPARATOR

Underwent laparoscopic TME operation, and the operator judged anastomotic blood supply with naked eyes and performed the surgical intervention based on the experience

Procedure: Non-application of near infrared-indocyanine green imaging system

Interventions

application of near infrared-indocyanine green imaging systemPROCEDURE

Underwent laparoscopic TME and colon-rectum or colon-anal anastomosis. near infrared-indocyanine green imaging system was used to evaluate the anastomotic flood perfusion during the operation; The operator may decide whether to change the surgical programme based on the outcome of the evaluation.

experimental group
Non-application of near infrared-indocyanine green imaging systemPROCEDURE

Underwent laparoscopic TME operation, and the operator judged anastomotic blood supply with naked eyes and performed the surgical intervention based on the experience

control group

Eligibility Criteria

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

You may qualify if:

  • The age was over 18 years at the time of diagnosis;
  • Diagnosis of rectal carcinoma and was confirmed by preoperative pathology;
  • MRI was performed before operation, and the distance between the lower margin of tumor and the anal margin was no more than 10cm;
  • The colon-rectum or colon-anus anastomosis was performed by laparoscopic TME operation
  • The "spleen area" was not free during the operation
  • Baseline clinical tumor stage TNM Ⅰ-Ⅲ phase: cT1-4N0-2M0 （AJCC-8 version）;

You may not qualify if:

  • Allergic to ICG or iodine;
  • Patients with intestinal obstruction, intestinal perforation, intestinal bleeding who need emergency operation;
  • Patients requiring combined organ resection that the tumor involves adjacent organs;
  • Patients with recurrence of tumor or distant metastasis;
  • Patients with multiple colorectal cancer;
  • Patients with history of inflammatory bowel disease or familial adenomatous polyposis;
  • Patients who have participated in or are participating in other clinical trials in the past four weeks;
  • Patients that ASA level is larger than III;
  • Physical condition: Patients with KPS less than or equal to 60 points or ECOG larger than or equal to 2 points;
  • Patients with hepatic dysfunction and MELD larger than 12 points;
  • Patients with a history of serious mental illness;
  • Pregnant or lactating women;
  • Patients who are improper to participate in the study in the opinion of the researchers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

RECRUITING

Beijing Friendship Hospital, Capital medical University

Beijing, Xicheng Dis, 100050, China

RECRUITING

Related Publications (1)

  • Sun L, Gao J, Wu G, Meng C, Yang Z, Wei P, Yao H, Zhang Z. Perfusion outcomes with near-infrared indocyanine green imaging system in laparoscopic total mesorectal excision for mid-rectal or low-rectal cancer (POSTER): a study protocol. BMJ Open. 2024 May 9;14(5):e079858. doi: 10.1136/bmjopen-2023-079858.

    PMID: 38724058DERIVED

MeSH Terms

Conditions

Rectal NeoplasmsAnastomotic Leak

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Zhongtao Zhang, Professor

    Beijing Friendship Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhongtao Zhang, Professor

CONTACT

13801060364zhangzht@medmail.com.cn

Hongwei Yao, Professor

CONTACT

13611015609yaohongwei@medmail.com.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of General Surgery of Beijing Friendship Hospital

Study Record Dates

First Submitted

July 6, 2019

First Posted

July 9, 2019

Study Start

November 16, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)