Esophageal Squamous Cell CarcinomaNCT04229524
Quantitative Assessment of Blood Supply in the Gastic Conduit With Fluorescence Angiography for Esophageal Reconstruction
A study testing Fluorescence angiography in people with Esophageal Squamous Cell Carcinoma, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
Trial summary
A single-institution, randomize controlled trial is to be held to evaluate the correlation between blood supply in the gastic conduit and the incidence of anastomotic fistula during radical operation for esophageal squamous cell carcinoma by fluorescence angiography. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Fluorescence angiography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 31 Dec 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Histologically confirmed esophageal squamous cell carcinoma and and potential resection;
- 2.Intend to undergo thoracic laparoscopy combined with three-incision esophageal cancer radical operation;
- 3.The stomach is used as an esophageal substitute for reconstruction;
- 4.Enrolled patients will adopt the esophagus bed pathway and round neck anastomosis method;
- 5.Have a performance status of 0 or 1 on the ECOG Performance Scale; Adequate organ function;
- 6.Be willing and able to provide written informed consent/assent for the trial.
Who cannot join
- 1.Histologically confirmed non-squamous cell carcinoma of the esophagus ;
- 2.The ECOG score of patient's physics >1;
- 3.Patients who use other organs instead of the esophagus;
- 4.Patients with vascular arch injury and need vascular anastomosis;
- 5.Patients with multiple complications such as heart disease or diabetes;
- 6.Other patients whom the medical practitioner considers inappropriate for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sichuan Cancer Hospital and Research Institute
Chengdu, Sichuan, 610041
Wenwu He, M.D., +8613350055340, wenwu_he@126.com
About this study
Official title: Quantitative Assessment of the Correlation Between Blood Supply in the Gastic Conduit and the Incidence of Anastomotic Fistula With Fluorescence Angiography for Esophageal Reconstruction
A single-institution, randomize controlled trial is to be held to evaluate the correlation between blood supply in the gastic conduit and the incidence of anastomotic fistula during radical operation for esophageal squamous cell carcinoma by fluorescence angiography.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Fluorescence angiography
- Keywords
- esophageal squamous cell carcinoma, blood supply, anastomotic fistula, fluorescence angiography
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescence angiographyProcedure or surgery
After the tube and stomach were made during surgery, the predetermined anastomosis position was marked with sutures in advance according to the doctor's experience, and then 0.04ml / kg indocyanine green injection was injected into the central vein. Next, dynamic observation and recording of the tube-gastric anastomosis area in 136 seconds using a fluorescent imaging system with a fixed focal length till the fluorescence reaching range and intensity. If the average value of the fluorescence value of the anastomosis position is greater than 30, then the anastomosis position may be according to the original plan or moved to the proximal part. If the average fluorescence value of the predetermined anastomosis position is less than 30, the anastomosis must move to proximal part ensure anastomosis with fluorescence value at least> 30.
| Study group | Role | What they receive |
|---|---|---|
| angiographic intervention group | Experimental | Enrolled patients will undergo thoracoscopy combined with a three-incision esophageal carcinoma radical mastectomy and two-field (chest-abdomen) lymph node dissection.Quantitative assessment of blood supply in the gastic conduit was performed using fluoroscopy before esophagogastric anastomosis. Receives: Procedure: Fluorescence angiography |
| control group | No intervention | The same surgical method as the experimental group.The only difference is that the position of the gastic conduit anastomosis is determined based on the experience of the doctor. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of anastomotic fistula
Anastomotic fistula is defined as an anastomotic fistula or any anastomotic dehiscence or leakage of saliva from a neck wound, confirmed by gastroscopy or upper gastrointestinal angiography, or purulent discharge from the chest or mediastinal drainage catheter. In addition, in this study, occult fistula was not included in the anastomotic fistula group when invasive treatment was not required.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Jun 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Dec 2021 (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 Esophageal Squamous Cell CarcinomaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongtao Han, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229524
- Sponsor's protocol ID
- 2001
- Status last verified
- Jun 2020
- First submitted
- 6 Jan 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
He W, Li Z, Deng X, Zheng K, Wang C, Peng L, Han Y, Leng X, Zhou Q. Fluorescence quantitative assessment of blood perfusion in the gastric conduit to reduce anastomotic leakage after esophagectomy: a randomized controlled trial. Surg Endosc. 2025 Oct;39(10):6644-6654. doi: 10.1007/s00464-025-12093-6. Epub 2025 Aug 20.
PubMed 40835759
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Assessment of the Correlation Between Blood Supply in the Gastic Conduit and the Incidence of Anastomotic Fistula With Fluorescence Angiography for Esophageal Reconstruction
- ClinicalTrials.gov ID
- NCT04229524
- Acronym / sponsor ID
- 2001
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- esophageal squamous cell carcinoma, blood supply, anastomotic fistula, fluorescence angiography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 18 Jan 2020 (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.
A single-institution, randomize controlled trial is to be held to evaluate the correlation between blood supply in the gastic conduit and the incidence of anastomotic fistula during radical operation for esophageal squamous cell carcinoma by fluorescence angiography.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| angiographic intervention group | Experimental | Procedure: Fluorescence angiographyEnrolled patients will undergo thoracoscopy combined with a three-incision esophageal carcinoma radical mastectomy and two-field (chest-abdomen) lymph node dissection.Quantitative assessment of blood supply in the gastic conduit was performed using fluoroscopy before esophagogastric anastomosis. |
| control group | No intervention | –The same surgical method as the experimental group.The only difference is that the position of the gastic conduit anastomosis is determined based on the experience of the doctor. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1.Histologically confirmed esophageal squamous cell carcinoma and and potential resection;
- 2.Intend to undergo thoracic laparoscopy combined with three-incision esophageal cancer radical operation;
- 3.The stomach is used as an esophageal substitute for reconstruction;
- 4.Enrolled patients will adopt the esophagus bed pathway and round neck anastomosis method;
- 5.Have a performance status of 0 or 1 on the ECOG Performance Scale; Adequate organ function;
Key exclusion criteria (6 listed)
- 1.Histologically confirmed non-squamous cell carcinoma of the esophagus ;
- 2.The ECOG score of patient's physics >1;
- 3.Patients who use other organs instead of the esophagus;
- 4.Patients with vascular arch injury and need vascular anastomosis;
- 5.Patients with multiple complications such as heart disease or diabetes;
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 |
|---|---|---|
| Fluorescence angiographyAfter the tube and stomach were made during surgery, the predetermined anastomosis position was marked with sutures in advance according to the doctor's experience, and then 0.04ml / kg indocyanine green injection was injected into the central vein. Next, dynamic observation and recording of the tube-gastric anastomosis area in 136 seconds using a fluorescent imaging system with a fixed focal length till the fluorescence reaching range and intensity. If the average value of the fluorescence value of the anastomosis position is greater than 30, then the anastomosis position may be according to the original plan or moved to the proximal part. If the average fluorescence value of the predetermined anastomosis position is less than 30, the anastomosis must move to proximal part ensure anastomosis with fluorescence value at least> 30. | Procedure or surgery | angiographic intervention group |
Primary outcome
The incidence of anastomotic fistula
Time frame: 3 months
Anastomotic fistula is defined as an anastomotic fistula or any anastomotic dehiscence or leakage of saliva from a neck wound, confirmed by gastroscopy or upper gastrointestinal angiography, or purulent discharge from the chest or mediastinal drainage catheter. In addition, in this study, occult fistula was not included in the anastomotic fistula group when invasive treatment was not required.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Derived from this study: PubMed 40835759He W, Li Z, Deng X, Zheng K, Wang C, Peng L, Han Y, Leng X, Zhou Q. Fluorescence quantitative assessment of blood perfusion in the gastric conduit to reduce anastomotic leakage after esophagectomy: a randomized controlled trial. Surg Endosc. 2025 Oct;39(10):6644-6654. doi: 10.1007/s00464-025-12093-6. Epub 2025 Aug 20.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluorescence angiography in people with Esophageal Squamous Cell Carcinoma, run by Sichuan Cancer Hospital and Research Institute at 1 site 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 6 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 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Wenwu He, M.D. (+8613350055340, wenwu_he@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of anastomotic fistula (time frame: 3 months). 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 NCT04229524, 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 9 Jun 2020.