Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anastomotic Leak | — | UNRESOLVED | — |
| Anastomotic Stenosis | — | UNRESOLVED | — |
| Endoscopic Evaluation | — | UNRESOLVED | — |
| Esophageal Neoplasm | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Recurrent Laryngeal Nerve Injuries | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- anastomotic leak
- timeFrame
- One week to six months after esophagectomy
- description
- leak of the anastomosis
- measure
- anastomotic stenosis
- timeFrame
- One week to six months after esophagectomy
- description
- stenosis of anastomosis
- measure
- laryngeal nerve injury
- timeFrame
- One week to six months after esophagectomy
- description
- hoarseness symptoms, recovery progression of recurrent laryngeal nerve injury
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available