Anastomotic Leak Esophagus
Conditions
Keywords
esophageal cancer, anastomotic leak, neoadjuvant chemoradiation, radiation dose, esophagectomy, outcomes
Brief summary
To investigate the clinical factors and preoperative treatment to the future anastomotic location of cervical esophagus that were correlated with anastomotic leaks in esophageal squamous cell carcinoma patients undergoing neoadjuvant chemoradiation and McKeown esophagectomy and to explore the prognosis of anastomotic leak.
Detailed description
The goal of this observational study is to investigate the clinical factors and preoperative treatment to the future anastomotic location of cervical esophagus that were correlated with anastomotic leaks in esophageal squamous cell carcinoma patients undergoing neoadjuvant chemoradiation and McKeown esophagectomy and to explore the postoperative complications, mortality, and long-term survival of different types of anastomotic leak.
Interventions
OTHERneoadjuvant chemoradiation and McKeown esophagectomy
Treatment protocol: 1. All patients were irradiated a total prescribed dose of 40-50.4 Gy in 20-28 fractions by a 6-8 MV photons linear accelerator with the intensity-modulated radiotherapy or volumetric modulated arc therapy technique. 2. Concurrent chemotherapy was cisplatin-based. 3. McKeown esophagectomy (three incision) consisted of thoracic esophageal mobilization with lymphadenectomy, abdominal exploration and stomach mobilization with lymphadenectomy, and subsequently left cervical incision for anastomosis. The lymphadenectomy was total two-field (thoracic + abdomen).
Sponsors
Chinese Institute of Food Science and Technology
Qiaoqiao Li
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* histologically confirmed ESCC; * clinically staged as T3-4aN0M0 or T1-4aN+M0 by the eighth edition of the American Joint Committee on Cancer and treated with nCRT followed by McKeown esophagectomy24; * aged 18-75 years; * Eastern Cooperative Oncology Group performance status score ≤ 2.
Exclusion criteria
* cervical esophageal cancer; * previously treated with chest radiotherapy, esophageal, or gastric surgery; * insufficient clinical data.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| anastomotic leak rate | Up to 1 month | According to the consensus on standardization of data collection for complications associated with esophagectomy by the Esophagectomy Complications Consensus Group (ECCG), anastomotic leak was defined as a full-thickness gastrointestinal defect involving the esophagus, anastomosis, staple line or conduit, which was diagnosed as extravasation of water-soluble contrast during a swallow study, postoperative esophageal barium X-ray or CT scan, visualization of anastomotic dehiscence or leak during endoscopy, or salivary fluid in the cervical region. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | From date of pathological diagnosis until the date of death from any cause or censoring, assessed up to 36 months | Overall survival (OS) was defined as the duration from the date of pathological diagnosis to the date of death or censoring. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pathologic complete response | Up to 1 month | Pathologic complete response (pCR) was defined as no evidence of residual tumor cells in the primary tumors and resected lymph nodes of the operative specimens. |
Countries
China
Outcome results
None listed