Anastomotic Leak EsophagusNCT06556355
Anastomotic Leaks in Esophageal Squamous Cell Carcinoma Patients After Trimodal Therapy
An observational study of Anastomotic Leak Esophagus, run by Qiaoqiao Li at 1 site in China.
Trial summary
To investigate the clinical factors and preoperative treatment to the future anastomotic location of cervical esophagus that were correlated with anastomotic leaks in esophageal squamous cell carcinoma patients undergoing neoadjuvant chemoradiation and McKeown esophagectomy and to explore the prognosis of anastomotic… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anastomotic Leak Esophagus
- What is being tested?
- neoadjuvant chemoradiation and McKeown esophagectomy
- How many people
- 218 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 15 Sep 2023
- Phase
- Observational
- 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
Study population: Consecutive patients with locally advanced thoracic ESCC who underwent nCRT and surgery at our center between 1 January 2015 and 31 December 2020 were retrospectively identified and analyzed.
Who may be able to join
- histologically confirmed ESCC;
- clinically staged as T3-4aN0M0 or T1-4aN+M0 by the eighth edition of the American Joint Committee on Cancer and treated with nCRT followed by McKeown esophagectomy24;
- aged 18-75 years;
- Eastern Cooperative Oncology Group performance status score ≤ 2.
Who cannot join
- cervical esophageal cancer;
- previously treated with chest radiotherapy, esophageal, or gastric surgery;
- insufficient clinical data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Preoperative Radiation Dose to the Cervical Esophagus on Anastomotic Leak in Esophageal Squamous Cell Carcinoma Patients After Neoadjuvant Chemoradiation and McKeown Esophagectomy: A Retrospective Analysis
To investigate the clinical factors and preoperative treatment to the future anastomotic location of cervical esophagus that were correlated with anastomotic leaks in esophageal squamous cell carcinoma patients undergoing neoadjuvant chemoradiation and McKeown esophagectomy and to explore the prognosis of anastomotic leak.
Read the detailed description
The goal of this observational study is to investigate the clinical factors and preoperative treatment to the future anastomotic location of cervical esophagus that were correlated with anastomotic leaks in esophageal squamous cell carcinoma patients undergoing neoadjuvant chemoradiation and McKeown esophagectomy and to explore the postoperative complications, mortality, and long-term survival of different types of anastomotic leak.
- Conditions
- Anastomotic Leak Esophagus
- Being tested
- neoadjuvant chemoradiation and McKeown esophagectomy
- Keywords
- esophageal cancer, anastomotic leak, neoadjuvant chemoradiation, radiation dose, esophagectomy, outcomes
- Medical subject headings
- Esophageal Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant chemoradiation and McKeown esophagectomyOther
Treatment protocol:
- All patients were irradiated a total prescribed dose of 40-50.4 Gy in 20-28 fractions by a 6-8 MV photons linear accelerator with the intensity-modulated radiotherapy or volumetric modulated arc therapy technique.
- Concurrent chemotherapy was cisplatin-based.
- McKeown esophagectomy (three incision) consisted of thoracic esophageal mobilization with lymphadenectomy, abdominal exploration and stomach mobilization with lymphadenectomy, and subsequently left cervical incision for anastomosis. The lymphadenectomy was total two-field (thoracic + abdomen).
| Study group | Role | What they receive |
|---|---|---|
| Overall patients | Consecutive patients with locally advanced thoracic ESCC who underwent nCRT and surgery at our center between 1 January 2015 and 31 December 2020. Receives: Other: neoadjuvant chemoradiation and McKeown esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
anastomotic leak rate
According to the consensus on standardization of data collection for complications associated with esophagectomy by the Esophagectomy Complications Consensus Group (ECCG), anastomotic leak was defined as a full-thickness gastrointestinal defect involving the esophagus, anastomosis, staple line or conduit, which was diagnosed as extravasation of water-soluble contrast during a swallow study, postoperative esophageal barium X-ray or CT scan, visualization of anastomotic dehiscence or leak during endoscopy, or salivary fluid in the cervical region.
Measured: Up to 1 month
Secondary outcomes (1)
Overall survival
Overall survival (OS) was defined as the duration from the date of pathological diagnosis to the date of death or censoring.
Measured: From date of pathological diagnosis until the date of death from any cause or censoring, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 Nov 2022
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomotic Leak EsophagusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qiaoqiao Li
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Institute of Food Science and Technology
- Responsible party
- Sponsor-investigator, Qiaoqiao Li, Sun Yat-Sen University Cancer Center
- Investigators
- Qiaoqiao Li, Study chair, Sun Yat-sen University Cancer Center, Guangzhou, ChinaChen Yang, Principal investigator, Sun Yat-sen University Cancer Center, Guangzhou, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556355
- Sponsor's protocol ID
- 202210172055000282645
- Status last verified
- Aug 2024
- First submitted
- 7 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research data are stored in an institutional repository and will be shared on reasonable request from the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preoperative Radiation Dose to the Cervical Esophagus on Anastomotic Leak in Esophageal Squamous Cell Carcinoma Patients After Neoadjuvant Chemoradiation and McKeown Esophagectomy: A Retrospective Analysis
- ClinicalTrials.gov ID
- NCT06556355
- Acronym / sponsor ID
- 202210172055000282645
- Conditions
- Anastomotic Leak Esophagus
- Keywords
- esophageal cancer, anastomotic leak, neoadjuvant chemoradiation, radiation dose, esophagectomy, outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Qiaoqiao LiUniversity, hospital or other
- Collaborators
- Chinese Institute of Food Science and Technology
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 16 Aug 2024 (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.
To investigate the clinical factors and preoperative treatment to the future anastomotic location of cervical esophagus that were correlated with anastomotic leaks in esophageal squamous cell carcinoma patients undergoing neoadjuvant chemoradiation and McKeown esophagectomy and to explore the prognosis of anastomotic leak.
Detailed description
The goal of this observational study is to investigate the clinical factors and preoperative treatment to the future anastomotic location of cervical esophagus that were correlated with anastomotic leaks in esophageal squamous cell carcinoma patients undergoing neoadjuvant chemoradiation and McKeown esophagectomy and to explore the postoperative complications, mortality, and long-term survival of different types of anastomotic leak.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overall patients | – | Other: neoadjuvant chemoradiation and McKeown esophagectomyConsecutive patients with locally advanced thoracic ESCC who underwent nCRT and surgery at our center between 1 January 2015 and 31 December 2020. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with locally advanced thoracic ESCC who underwent nCRT and surgery at our center between 1 January 2015 and 31 December 2020 were retrospectively identified and analyzed.
Key inclusion criteria (4 listed)
- histologically confirmed ESCC;
- clinically staged as T3-4aN0M0 or T1-4aN+M0 by the eighth edition of the American Joint Committee on Cancer and treated with nCRT followed by McKeown esophagectomy24;
- aged 18-75 years;
- Eastern Cooperative Oncology Group performance status score ≤ 2.
Key exclusion criteria (3 listed)
- cervical esophageal cancer;
- previously treated with chest radiotherapy, esophageal, or gastric surgery;
- insufficient clinical data.
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 |
|---|---|---|
| neoadjuvant chemoradiation and McKeown esophagectomyTreatment protocol: 1. All patients were irradiated a total prescribed dose of 40-50.4 Gy in 20-28 fractions by a 6-8 MV photons linear accelerator with the intensity-modulated radiotherapy or volumetric modulated arc therapy technique. 2. Concurrent chemotherapy was cisplatin-based. 3. McKeown esophagectomy (three incision) consisted of thoracic esophageal mobilization with lymphadenectomy, abdominal exploration and stomach mobilization with lymphadenectomy, and subsequently left cervical incision for anastomosis. The lymphadenectomy was total two-field (thoracic + abdomen). | Other | Overall patients |
Primary outcome
anastomotic leak rate
Time frame: Up to 1 month
According to the consensus on standardization of data collection for complications associated with esophagectomy by the Esophagectomy Complications Consensus Group (ECCG), anastomotic leak was defined as a full-thickness gastrointestinal defect involving the esophagus, anastomosis, staple line or conduit, which was diagnosed as extravasation of water-soluble contrast during a swallow study, postoperative esophageal barium X-ray or CT scan, visualization of anastomotic dehiscence or leak during endoscopy, or salivary fluid in the cervical region.
1 secondary outcome
Overall survival
Time frame: From date of pathological diagnosis until the date of death from any cause or censoring, assessed up to 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Individual participant dataSharing planned: Yes. The research data are stored in an institutional repository and will be shared on reasonable request from the corresponding author.
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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.
Qiaoqiao Li study chair
Sun Yat-sen University Cancer Center, Guangzhou, China
Chen Yang principal investigator
Sun Yat-sen University Cancer Center, Guangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anastomotic Leak Esophagus, run by Qiaoqiao Li 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 16 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anastomotic leak rate (time frame: Up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2024.