Esophageal NeoplasmNCT06348381
Prediction of Anastomotic Complications and Recurrent Laryngeal Nerve Injury Based on Postoperative Early Endoscopic Evaluation
An observational study of Esophageal Neoplasm and Anastomotic Leak, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
Analyze the correlation between the conformity of the anatomy (based on endoscopic examination) and postoperative anastomotic fistula and anastomotic stenosis; establish an anastomotic classification; and construct a predictive model combined with perioperative-related test indicators to provide more accurate risk… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Neoplasm, Anastomotic Leak, Recurrent Laryngeal Nerve Injuries
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 31 Dec 2025
- 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 80 years
- All sexes
- Adult, Older adult
Study population: Patients who received radical resection of esophageal cancer in our hospital from April 2024 to July 2024.
Who may be able to join
- Diagnosed with esophageal squamous cell carcinoma;
- 18 - 80 years old;
- ECOG PS 0-1;
- Thoracic esophageal cancer (20-40cm from the incisors);
- Received radical resection of esophageal cancer in our hospital from April 2024 to July 2024;
- Received the McKeown procedure in our hospital's single treatment group;
- Received gastric reconstruction and cervical anastomosis with a side-to-side anastomotic device;
- Complete clinical materials.
Who cannot join
- History of other malignant tumors;
- Incomplete or missing clinical materials;
- Received combined surgery (total laryngectomy + esophagectomy, esophagectomy + lung resection, esophagectomy + aorta, etc.);
- Gastric reconstruction or cervical anastomosis with a side-to-side anastomotic device was not performed;
- Patients who underwent 3-field lymph node dissection;
- Patients with clear intraoperative recurrent laryngeal nerve section;
- Highly suspected anastomotic fistula before the first endoscopic evaluation (abnormal secretion at the cervical anastomotic site, abnormal drainage fluid in the chest tube, and high fever that other reasons cannot explain);
- Lost to follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital, Shanghai Jiao Tong University
Shanghai, SH 21
Zhigang Li, Doctor, 86-18930619260, zhigang.li@shchest.org
About this study
Official title: Prediction of Anastomotic Complications and Recurrent Laryngeal Nerve Injury Based on Postoperative Early Endoscopic Evaluation: a Prospective, Observational, Non-interventional Study
Analyze the correlation between the conformity of the anatomy (based on endoscopic examination) and postoperative anastomotic fistula and anastomotic stenosis; establish an anastomotic classification; and construct a predictive model combined with perioperative-related test indicators to provide more accurate risk assessment for clinical practice. Analyze the natural recovery process of postoperative recurrent laryngeal nerve injury in esophageal cancer by tracking vocal cord movement (based on endoscopic examination) and hoarseness symptoms; combined with perioperative related surgical and laboratory indicators, identify the relevant risk factors associated with delayed recovery of recurrent laryngeal nerve injury.
- Conditions
- Esophageal Neoplasm, Anastomotic Leak, Recurrent Laryngeal Nerve Injuries, Anastomotic Stenosis, Endoscopic Evaluation
- Being tested
- No intervention
- Medical subject headings
- Esophageal Neoplasms, Anastomotic Leak, Recurrent Laryngeal Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
anastomotic leak
leak of the anastomosis
Measured: One week to six months after esophagectomy
anastomotic stenosis
stenosis of anastomosis
Measured: One week to six months after esophagectomy
laryngeal nerve injury
hoarseness symptoms, recovery progression of recurrent laryngeal nerve injury
Measured: One week to six months after esophagectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhigang Li, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348381
- Sponsor's protocol ID
- IS24030
- Status last verified
- Mar 2024
- First submitted
- 30 Mar 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Anastomotic Complications and Recurrent Laryngeal Nerve Injury Based on Postoperative Early Endoscopic Evaluation: a Prospective, Observational, Non-interventional Study
- ClinicalTrials.gov ID
- NCT06348381
- Acronym / sponsor ID
- IS24030
- Conditions
- Esophageal Neoplasm, Anastomotic Leak, Recurrent Laryngeal Nerve Injuries, Anastomotic Stenosis, Endoscopic Evaluation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Apr 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.
Analyze the correlation between the conformity of the anatomy (based on endoscopic examination) and postoperative anastomotic fistula and anastomotic stenosis; establish an anastomotic classification; and construct a predictive model combined with perioperative-related test indicators to provide more accurate risk assessment for clinical practice. Analyze the natural recovery process of postoperative recurrent laryngeal nerve injury in esophageal cancer by tracking vocal cord movement (based on endoscopic examination) and hoarseness symptoms; combined with perioperative related surgical and laboratory indicators, identify the relevant risk factors associated with delayed recovery of recurrent laryngeal nerve injury.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who received radical resection of esophageal cancer in our hospital from April 2024 to July 2024.
Key inclusion criteria (8 listed)
- Diagnosed with esophageal squamous cell carcinoma;
- 18 - 80 years old;
- ECOG PS 0-1;
- Thoracic esophageal cancer (20-40cm from the incisors);
- Received radical resection of esophageal cancer in our hospital from April 2024 to July 2024;
Key exclusion criteria (8 listed)
- History of other malignant tumors;
- Incomplete or missing clinical materials;
- Received combined surgery (total laryngectomy + esophagectomy, esophagectomy + lung resection, esophagectomy + aorta, etc.);
- Gastric reconstruction or cervical anastomosis with a side-to-side anastomotic device was not performed;
- Patients who underwent 3-field lymph node dissection;
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 |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
anastomotic leak
Time frame: One week to six months after esophagectomy
leak of the anastomosis
anastomotic stenosis
Time frame: One week to six months after esophagectomy
stenosis of anastomosis
laryngeal nerve injury
Time frame: One week to six months after esophagectomy
hoarseness symptoms, recovery progression of recurrent laryngeal nerve injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
Shanghai Chest Hospital, Shanghai Jiao Tong University
Shanghai, 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 Esophageal Neoplasm and Anastomotic Leak, run by Shanghai Chest Hospital 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 8 inclusion and 8 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 4 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anastomotic leak (time frame: One week to six months after esophagectomy). The study lists 3 primary outcomes in all. 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 4 Apr 2024.