Anastomotic Leaks in Esophageal Squamous Cell Carcinoma Patients After Trimodal Therapy

NCT06556355 | Completed

• 1 other identifier: 202210172055000282645
• Study Type: observational
• Target: 218
• Locations: 1 country
• Sites: 1

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.

Conditions

Anastomotic Leak Esophagus

Keywords

esophageal cancer; anastomotic leak; neoadjuvant chemoradiation; radiation dose; esophagectomy; outcomes

Outcome Measures

Primary Outcomes (1)

• anastomotic leak rate

  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.

  Up to 1 month

Secondary Outcomes (1)

• Overall survival

  From date of pathological diagnosis until the date of death from any cause or censoring, assessed up to 36 months

Other Outcomes (1)

• Pathologic complete response

  Up to 1 month

Study Arms (1)

Overall patients

Consecutive patients with locally advanced thoracic ESCC who underwent nCRT and surgery at our center between 1 January 2015 and 31 December 2020.

Other: neoadjuvant chemoradiation and McKeown esophagectomy

Interventions

neoadjuvant chemoradiation and McKeown esophagectomy OTHER

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).

Overall patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive patients with locally advanced thoracic ESCC who underwent nCRT and surgery at our center between 1 January 2015 and 31 December 2020 were retrospectively identified and analyzed.

You may qualify if:

• 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.

You may not qualify if:

• cervical esophageal cancer;
• previously treated with chest radiotherapy, esophageal, or gastric surgery;
• insufficient clinical data.

Sponsors & Collaborators

• Qiaoqiao Li: lead
• Chinese Institute of Food Science and Technology: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Anastomotic Leak

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• Qiaoqiao Li

  Sun Yat-sen University Cancer Center, Guangzhou, China

  STUDY CHAIR

• Chen Yang

  Sun Yat-sen University Cancer Center, Guangzhou, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Medical Officer

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 16, 2024
• Study Start: November 1, 2022
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

CN (1)