Comparison of Long-term Survival and Quality of Life After Minimally Invasive Esophagectomy Versus Open Esophagectomy

NCT06147180 | Not Yet Recruiting DMC

• 1 other identifier: MR-37-23-034233
• Study Type: observational
• Target: 1,474
• Locations: 1 country
• Sites: 1

Brief Summary

To analyze and compare the long-term recurrence-free survival rate, overall survival rate and quality of survival after minimally invasive esophagectomy and open esophagectomy, and to conduct subgroup analysis according to the type of esophageal cancer and pathological stage, etc., and to explore more deeply the differences between minimally invasive esophagectomy and open esophagectomy in terms of the benefits for different types of patients, so as to provide reference for the selection of the clinical surgical methods. We will also use the available data to analyze the influence of other factors on patients\' long-term survival after surgery.

Conditions

Esophagus Cancer; Esophagectomy; Quality of Life; Survival

Keywords

esophagus Cancer; invasive esophagectomy; open esophagectomy; long-term survival; quality of life

Outcome Measures

Primary Outcomes (2)

• Survival Information

  Dead or alive 5 years after surgery

  From enrollment to 5 years after surgery

• score of Quality of life

  Measured with EORTC QLQ-OES18 Quality of Life Questionnaire

  From enrollment to 5 years after surgery

Secondary Outcomes (1)

• Recurrence or metastasis

  From enrollment to 5 years after surgery

Study Arms (2)

Minimally invasive esophageal cancer resection group

Surgical Procedures: minimally invasive esophagectomy

Open esophageal cancer resection group

Surgical Procedures: open esophagectomy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who had undergone esophageal cancer resection at the Department of Thoracic Surgery, Qilu Hospital, Shandong University, between 2013 and 2021.

You may qualify if:

• Patients who had undergone esophageal cancer resection at the Department of Thoracic Surgery, Qilu Hospital, Shandong University, between 2013 and 2021, with pathology results confirming esophageal squamous carcinoma, adenocarcinoma, or other malignant tumors.
• The surgery was successfully completed, the patient was safely discharged from the hospital, the postoperative follow-up was successful, and if the follow-up patient died, his or her death was due to natural causes.

You may not qualify if:

• Perioperative patient deaths, pathologic findings other than those listed above, loss of visits, and postoperative unnatural deaths.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Ji'nan, Shandong, 250012, China

Location

Related Publications (8)

• Li Z, Liu C, Liu Y, Yao S, Xu B, Dong G. Comparisons between minimally invasive and open esophagectomy for esophageal cancer with cervical anastomosis: a retrospective study. J Cardiothorac Surg. 2020 Jun 8;15(1):128. doi: 10.1186/s13019-020-01182-3.

  PMID: 32513211 BACKGROUND

• Zheng Y, Li Y, Liu X, Sun H, Shen S, Ba Y, Wang Z, Liu S, Xing W. Minimally Invasive Versus Open McKeown for Patients with Esophageal Cancer: A Retrospective Study. Ann Surg Oncol. 2021 Oct;28(11):6329-6336. doi: 10.1245/s10434-021-10105-y. Epub 2021 May 13.

  PMID: 33987755 BACKGROUND

• Ising MS, Smith SA, Trivedi JR, Martin RCG, Phillips P, Van Berkel V, Fox MP. Minimally Invasive Esophagectomy Is Associated with Superior Survival Compared to Open Surgery. Am Surg. 2023 May;89(5):1833-1843. doi: 10.1177/00031348221078962. Epub 2022 Mar 23.

  PMID: 35317621 BACKGROUND

• Chen HS, Lin CH, Wu SC, Wang BY. Comparing survival between neoadjuvant chemoradiotherapy followed by open or thoracoscopic oesophagectomy in patients with oesophageal squamous cell carcinoma. Eur J Cardiothorac Surg. 2022 Jul 11;62(2):ezac114. doi: 10.1093/ejcts/ezac114.

  PMID: 35303068 BACKGROUND

• van der Sluis PC, van der Horst S, May AM, Schippers C, Brosens LAA, Joore HCA, Kroese CC, Haj Mohammad N, Mook S, Vleggaar FP, Borel Rinkes IHM, Ruurda JP, van Hillegersberg R. Robot-assisted Minimally Invasive Thoracolaparoscopic Esophagectomy Versus Open Transthoracic Esophagectomy for Resectable Esophageal Cancer: A Randomized Controlled Trial. Ann Surg. 2019 Apr;269(4):621-630. doi: 10.1097/SLA.0000000000003031.

  PMID: 30308612 BACKGROUND

• Knitter S, Andreou A, Hofmann T, Chopra S, Denecke C, Thuss-Patience PC, Kroll D, Bahra M, Schmelzle M, Pratschke J, Biebl M. Minimally Invasive Versus Open Ivor-Lewis Esophagectomy for Esophageal Cancer or Cancer of the Gastroesophageal Junction: Comparison of Postoperative Outcomes and Long-term Survival Using Propensity Score Matching Analysis. Anticancer Res. 2021 Jul;41(7):3499-3510. doi: 10.21873/anticanres.15137.

  PMID: 34230145 BACKGROUND

• Gottlieb-Vedi E, Kauppila JH, Mattsson F, Lindblad M, Nilsson M, Lagergren P, Rouvelas I, Lagergren J; FINEGO group. Long-term Survival in Esophageal Cancer After Minimally Invasive Esophagectomy Compared to Open Esophagectomy. Ann Surg. 2022 Dec 1;276(6):e744-e748. doi: 10.1097/SLA.0000000000004645. Epub 2021 Jan 20.

  PMID: 33480612 BACKGROUND

• Giulini L, Dubecz A. Minimally invasive versus open oesophagectomy for cancer: propensity score analysis improves results' reliability but matching criteria need to be selected accurately. Eur J Cardiothorac Surg. 2022 Jul 11;62(2):ezac192. doi: 10.1093/ejcts/ezac192. No abstract available.

  PMID: 35349668 BACKGROUND

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 Officials

• Hui Tian, Doctor

  Qilu Hospital of Shandong University

  STUDY DIRECTOR

Central Study Contacts

Hui Tian, Doctor

CONTACT

86 + 18560080016; tianhuiql@email.sdu.edu.cn

Junjie Liu

CONTACT

86 + 15306343656; 2862794172@qq.com

Study Design

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

Study Record Dates

• First Submitted: November 19, 2023
• First Posted: November 27, 2023
• Study Start: November 27, 2023
• Primary Completion: December 31, 2023
• Study Completion (Estimated): August 31, 2026
• Last Updated: November 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)