Perioperative Outcomes and Survival of Inflatable Video-Assisted Mediastinoscopic Transhiatal Esophagectomy for Selected Esophageal Cancer

NCT07182266 | Completed

• 3 other identifiers: B2024-122R20ZR1411600SHDC2020CR4039
• Study Type: observational
• Target: 1,661
• Locations: 1 country
• Sites: 1

Brief Summary

Perioperative and oncologic benefits of inflatable video-assisted mediastinoscopic transhiatal esophagectomy (IVMTE) are unclear. This retrospective study aimed to compare the differences in perioperative outcomes and survival between IVMTE and video-assisted McKeown esophagectomy (VME).

Conditions

Esophageal Carcinoma

Keywords

esophageal carcinoma; mediastinoscopic; McKeown

Outcome Measures

Primary Outcomes (2)

• Survival

  Disease-Free Survival, Overall Survival

  within 2 years after surgery

• Complication

  follow the guidelines of the Esophageal Complications Consensus Group (ECCG) recommendations and Clavien-Dindo classification

  perioperative

Study Arms (2)

IVMTE

The patient was positioned supine. A 5-cm cervical incision was made along the anterior border of the left sternocleidomastoid muscle as the main surgical route. The skin and subcutaneous tissues were carefully incised in layers. The left recurrent laryngeal nerve (RLN) was identified and traced, followed by mobilization of the cervical esophagus. A lap protector was inserted into the left incision to create a closed cavity, and the mediastinum was insufflated with carbon dioxide at 8 mmHg. Three 5-mm trocars were used for the specialized retractor, LigaSure Maryland jaw sealer, and mediastinoscope. Then, the esophagus was dissected up to the level of the carina or the inferior pulmonary vein. During this process, mediastinal lymph nodes were also removed, including bilateral RLN, paraesophageal, tracheobronchial, and subcarinal nodes. If necessary, the incision was then extended to the right neck to facilitate the dissection of the right cervical lymph nodes.

VME

traditional video-assisted McKeown esophagectomy

Eligibility Criteria

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

Study Population

From January 2021 to December 2023, patients with esophageal cancer who received IVMTE or VME were identified from the prospectively maintained esophageal cancer database at Zhongshan Hospital, Fudan University

You may qualify if:

• (I) primary esophageal cancer confirmed by endoscopic biopsy and (II) diagnosed resectable tumors based on positron emission tomography-computed tomography (PET-CT) according to the International Union Against Cancer Tumor, Node, Metastasis (TNM) Classification (8th edition)

You may not qualify if:

• (I) presence of other advanced malignancies, (II) insufficient clinical data, or (III) postoperative follow-up of less than 12 months.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 19, 2025
• Study Start: January 4, 2021
• Primary Completion: December 29, 2023
• Study Completion: September 1, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

CN (1)