Rectal NeoplasmsPOSTERNCT04012645
Perfusion Outcomes With Near Infrared-Indocyanine Green Imaging System in Laparoscopic Total Mesorectal Excision for Mid- or Low-rectal CanceR
A study testing application of near infrared-indocyanine green imaging system and Non-application of near infrared-indocyanine green imaging system in people with Rectal Neoplasms, run by Zhongtao Zhang at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- application of near infrared-indocyanine green imaging system and Non-application of near infrared-indocyanine green imaging system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 547 participants
- Where
- 2 sitesChina
- Study dates
- 16 Nov 2023to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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）;
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050
Hongwei Yao, M.D., +8613611015609, yaohongwei@medmail.com.cn
- Recruiting
Beijing Friendship Hospital, Capital medical University
Beijing, Xicheng Dis, 100050
Zhongtao Zhang, MD, 13801060364, zhangzht@medmail.com.cn
Zhicheng Ge, MD, 13601032257, gezhicheng2000@sina.com
About this study
Official title: A Study Assessing Perfusion Outcomes With Near Infrared-Indocyanine Green Imaging System in Laparoscopic Total Mesorectal Excision for Mid- or Low-rectal CanceR
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.
Read the detailed description
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.
- Conditions
- Rectal Neoplasms
- Being tested
- application of near infrared-indocyanine green imaging system, Non-application of near infrared-indocyanine green imaging system
- Keywords
- Rectal Neoplasms, Indocyanine Green, Anastomotic Leakage
- Medical subject headings
- Rectal Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
application of near infrared-indocyanine green imaging systemProcedure or surgery
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.
Non-application of near infrared-indocyanine green imaging systemProcedure or surgery
Underwent laparoscopic TME operation, and the operator judged anastomotic blood supply with naked eyes and performed the surgical intervention based on the experience
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Underwent laparoscopic TME and colon-rectum or colon-anal anastomosis. near infrared-indocyanine green imaging system was used during the surgeries. Receives: 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 Receives: Procedure: Non-application of near infrared-indocyanine green imaging system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 30 days after operation
Secondary outcomes (1)
the change of surgical precedure
the change of intraoperative decision, including: (1) The change of the position of intestinal dissection; (2) Anastomotic stoma was removed and rebuilt or re-performed hartmann operation; (3) The performance of unplanned, preventive orifice, etc. due to ICG test results.
Measured: within the operation time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start16 Nov 2023
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 547 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongtao Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Beijing Chao Yang Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Chinese PLA General Hospital, Peking University People's Hospital, Peking University Cancer Hospital & Institute, Beijing Hospital, Changhai Hospital, Ruijin Hospital, RenJi Hospital, Fudan University, Guangdong Provincial People's Hospital, Southern Medical University, China, First Hospital of China Medical University, The First Hospital of Jilin University, The First Affiliated Hospital with Nanjing Medical University, Fujian Medical University Union Hospital, First Affiliated Hospital of Chongqing Medical University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor-investigator, Zhongtao Zhang, Beijing Friendship Hospital
- Investigators
- Zhongtao Zhang, Professor, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012645
- Sponsor's protocol ID
- Poster
- Acronym
- POSTER
- Status last verified
- Nov 2023
- First submitted
- 6 Jul 2019
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38724058
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Assessing Perfusion Outcomes With Near Infrared-Indocyanine Green Imaging System in Laparoscopic Total Mesorectal Excision for Mid- or Low-rectal CanceR
- ClinicalTrials.gov ID
- NCT04012645
- Acronym / sponsor ID
- POSTER / Poster
- Conditions
- Rectal Neoplasms
- Keywords
- Rectal Neoplasms, Indocyanine Green, Anastomotic Leakage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 547 participants (estimated)
- Lead sponsor
- Zhongtao ZhangUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Beijing Chao Yang Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Chinese PLA General Hospital, Peking University People's Hospital, Peking University Cancer Hospital & Institute, Beijing Hospital, Changhai Hospital, Ruijin Hospital, RenJi Hospital, Fudan University, Guangdong Provincial People's Hospital, Southern Medical University, China, First Hospital of China Medical University, The First Hospital of Jilin University, The First Affiliated Hospital with Nanjing Medical University, Fujian Medical University Union Hospital, First Affiliated Hospital of Chongqing Medical University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 9 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Procedure: application of near infrared-indocyanine green imaging systemUnderwent laparoscopic TME and colon-rectum or colon-anal anastomosis. near infrared-indocyanine green imaging system was used during the surgeries. |
| control group | Active comparator | Procedure: Non-application of near infrared-indocyanine green imaging systemUnderwent laparoscopic TME operation, and the operator judged anastomotic blood supply with naked eyes and performed the surgical intervention based on the experience |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| application of near infrared-indocyanine green imaging systemUnderwent 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. | Procedure or surgery | experimental group |
| Non-application of near infrared-indocyanine green imaging systemUnderwent laparoscopic TME operation, and the operator judged anastomotic blood supply with naked eyes and performed the surgical intervention based on the experience | Procedure or surgery | control group |
Primary outcome
Anastomotic leakage
Time frame: within 30 days after operation
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.
1 secondary outcome
the change of surgical precedure
Time frame: within the operation time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 38724058Sun 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhongtao Zhang, Professor principal investigator
Beijing Friendship Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing application of near infrared-indocyanine green imaging system and Non-application of near infrared-indocyanine green imaging system in people with Rectal Neoplasms, run by Zhongtao Zhang at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhongtao Zhang, Professor (13801060364, zhangzht@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic leakage (time frame: within 30 days after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04012645, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.