Clinical trial NCT06348381: Prediction of Anastomotic Complications and Recurrent Laryngeal Nerve Injury Based on Postoperative Early Endoscopic Evaluation
Official title: Prediction of Anastomotic Complications and Recurrent Laryngeal Nerve Injury Based on Postoperative Early Endoscopic Evaluation: a Prospective, Observational, Non-interventional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Neoplasm
Anastomotic Leak
Recurrent Laryngeal Nerve Injuries
Anastomotic Stenosis
Endoscopic Evaluation
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received radical resection of esophageal cancer in our hospital from April 2024 to July 2024.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: anastomotic leak
timeFrame: One week to six months after esophagectomy
measure: anastomotic stenosis
timeFrame: One week to six months after esophagectomy
measure: laryngeal nerve injury
timeFrame: One week to six months after esophagectomy
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital, Shanghai Jiao Tong University
Study officials:
References: