Suspended

POSTERA Study Assessing Perfusion Outcomes With Near Infrared-Indocyanine Green Imaging System in Laparoscopic Total Mesorectal Excision for Mid- or Low-rectal CanceR

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What is being tested

application of near infrared-indocyanine green imaging system

+ Non-application of near infrared-indocyanine green imaging system

Procedure
Who is being recruted

Digestive System Diseases+12

+ Digestive System Neoplasms

+ Gastrointestinal Diseases

From 18 to 80 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: November 2023
See protocol details

Summary

Principal SponsorZhongtao Zhang
Study ContactZhongtao Zhang, ProfessorMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 16, 2023

Actual date on which the first participant was enrolled.

In total mesorectal excision of rectal cancer, accurate assessment of rectal anastomotic blood supply is crucial: for insufficient anastomotic blood supply is an important cause of postoperative anastomotic leakage, and once anastomotic leakage occurs, the perioperative mortality rate of patients is reportedly 16%. In the past, the assessment of anastomotic blood supply mainly depended on the experience of the surgeon and lacked objective and accurate assessment methods. In recent years, the application of near-infrared fluorescence laparoscopic imaging technology has provided a new way to accurately evaluate anastomotic perfusion. At present, the technology has been applied to evaluate anastomotic blood supply in colorectal cancer surgery worldwide, and its safety and reliability have been confirmed. However, whether the application of this technology can reduce the incidence of anastomotic leakage after total mesorectal excision for rectal cancer and thus benefit patients still needs high-level evidence-based medical evidence support with multi-centers and large samples.Thus, a multicenter, prospective, and randomized controlled clinical study of patients with mid- or low- rectal cancer who received laparoscopic TME surgery was intend to conduct 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.

Official TitleA Study Assessing Perfusion Outcomes With Near Infrared-Indocyanine Green Imaging System in Laparoscopic Total Mesorectal Excision for Mid- or Low-rectal CanceR
Principal SponsorZhongtao Zhang
Study ContactZhongtao Zhang, ProfessorMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

547 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SitePathologic ProcessesPostoperative ComplicationsRectal DiseasesRectal NeoplasmsPathological Conditions, Signs and SymptomsColorectal NeoplasmsAnastomotic Leak

Criteria

6 inclusion criteria required to participate
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

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13 exclusion criteria prevent from participating
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;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Beijing Friendship Hospital

Beijing, ChinaOpen Beijing Friendship Hospital in Google Maps
Recruiting

Beijing Friendship Hospital, Capital medical University

Beijing, China
Suspended2 Study Centers