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

Prediction of Anastomotic Complications and Recurrent Laryngeal Nerve Injury Based on Postoperative Early Endoscopic Evaluation: a Prospective, Observational, Non-interventional Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06348381
Enrollment
250
Registered
2024-04-04
Start date
2024-04-01
Completion date
2025-12-31
Last updated
2024-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomotic Leak, Anastomotic Stenosis, Endoscopic Evaluation, Esophageal Neoplasm, Recurrent Laryngeal Nerve Injuries

Brief 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.

Interventions

OTHERNo intervention

No intervention

Sponsors

Shanghai Chest Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

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

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.

Design outcomes

Primary

MeasureTime frameDescription
anastomotic leakOne week to six months after esophagectomyleak of the anastomosis
anastomotic stenosisOne week to six months after esophagectomystenosis of anastomosis
laryngeal nerve injuryOne week to six months after esophagectomyhoarseness symptoms, recovery progression of recurrent laryngeal nerve injury

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026