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

NCT06348381 — Unknown, 250 participants, Shanghai Chest Hospital
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Prediction of Anastomotic Complications and Recurrent Laryngeal Nerve Injury Based on Postoperative Early Endoscopic Evaluation: a Prospective, Observational, Non-interventional Study

RegistryNCT06348381
StatusUnknown
Study typeObservational
Enrollment250 (Estimated)
SponsorShanghai Chest Hospital (Other)
ConditionsEsophageal Neoplasm, Anastomotic Leak, Recurrent Laryngeal Nerve Injuries, Anastomotic Stenosis, Endoscopic Evaluation
InterventionsNo intervention (Other)
Datesstart 2024-04-01 (estimated), primary completion 2025-04-01 (estimated), completion 2025-12-31 (estimated), first posted 2024-04-04, last updated 2024-04-04
Locations1 site in China

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-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.

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+Arms and interventions

  • No intervention (Other): No intervention

+Outcome measures

Primary outcomes

  • anastomotic leak [One week to six months after esophagectomy]: leak of the anastomosis
  • anastomotic stenosis [One week to six months after esophagectomy]: stenosis of anastomosis
  • laryngeal nerve injury [One week to six months after esophagectomy]: hoarseness symptoms, recovery progression of recurrent laryngeal nerve injury

+Eligibility

Sex: All, ages: 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.

+Locations (1)

FacilityCityCountryStatus
Shanghai Chest Hospital, Shanghai Jiao Tong UniversityShanghaiChinaRecruiting

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