CClinicalTrials.gg
Sign In
RecruitingNCT06348381Updated Apr 4, 2024

Prediction of Anastomotic Complications and Recurrent Laryngeal Nerve Injury Based on Postoperative Early Endoscopic Evaluation

An observational study in Esophageal Neoplasm, Anastomotic Leak and Recurrent Laryngeal Nerve Injuries, sponsored by Shanghai Chest Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-04.

Sponsored by Shanghai Chest Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 6 months ago, but the record still lists the study as recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Esophageal Neoplasm
  • Anastomotic Leak
  • Recurrent Laryngeal Nerve Injuries
  • Anastomotic Stenosis
  • Endoscopic Evaluation
03

In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

This study's planned enrollment of 250 is above the median of 200 across 341 observational studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

Shanghai Chest Hospital is the lead sponsor of 194 studies on the registry; 94 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients who received radical resection of esophageal cancer in our hospital from April 2024 to July 2024.

Inclusion criteria

  1. Diagnosed with esophageal squamous cell carcinoma;
  2. 18 - 80 years old;
  3. ECOG PS 0-1;
  4. Thoracic esophageal cancer (20-40cm from the incisors);
  5. Received radical resection of esophageal cancer in our hospital from April 2024 to July 2024;
  6. Received the McKeown procedure in our hospital's single treatment group;
  7. Received gastric reconstruction and cervical anastomosis with a side-to-side anastomotic device;
  8. Complete clinical materials.

Exclusion criteria

Exclusion Criteria:

  1. History of other malignant tumors;
  2. Incomplete or missing clinical materials;
  3. Received combined surgery (total laryngectomy + esophagectomy, esophagectomy + lung resection, esophagectomy + aorta, etc.);
  4. Gastric reconstruction or cervical anastomosis with a side-to-side anastomotic device was not performed;
  5. Patients who underwent 3-field lymph node dissection;
  6. Patients with clear intraoperative recurrent laryngeal nerve section;
  7. 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);
  8. Lost to follow-up.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (estimated)
Patient registry
No

Interventions

  • OtherNo intervention

    No intervention

06

What researchers measure

Primary outcomes

  1. anastomotic leak

    leak of the anastomosis

    Time frame: One week to six months after esophagectomy

  2. anastomotic stenosis

    stenosis of anastomosis

    Time frame: One week to six months after esophagectomy

  3. laryngeal nerve injury

    hoarseness symptoms, recovery progression of recurrent laryngeal nerve injury

    Time frame: One week to six months after esophagectomy

07

Study locations

1 of 1 sites recruiting
  • Shanghai Chest Hospital, Shanghai Jiao Tong University
    Shanghai, SH 21, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06348381
Lead sponsor
Shanghai Chest Hospital
Responsible party
Zhigang Li (Deputy director of department of thoracic surgery, Shanghai Chest Hospital) — Principal investigator
First posted
Apr 4, 2024
Start date
Apr 1, 2024 (estimated)
Primary completion
Apr 1, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Apr 4, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Esophageal Neoplasms→

Other studies from this sponsor

Shanghai Chest Hospital

Start the discussion