CClinicalTrials.gg
Status unknownNCT02448966Updated May 20, 2015

Traditional Three-incision Esophagectomy Versus Minimally Invasive Thorascopic and Laparoscopic Esophagectomy

An observational study in Esophageal Cancer, sponsored by Chinese Academy of Medical Sciences. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-05-20.

Sponsored by Chinese Academy of Medical Sciences · Observational

The sponsor has not verified this record recently (last verified May 2015), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years to 75 Years
Sex
All
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Study summary

Esophageal carcinoma is an aggressive malignancy with poor prognosis. Surgical resection remains the most effective method for this malignant disease. VATS esophagectomy has become more and more popular in China and around the world. Although VATS esophagectomy has been proven to be effective in preventing respiratory complications, there is still no ample evidences to demonstrate that VATS esophagectomy is as effective as traditional three-incision esophagectomy in lymph node dissection and is equal or superior in long-term survival. The purpose of this large scale prospective observational study is to compare the minimally invasive thorascopic/laparoscopic esophagectomy with traditional three-incision esophagectomy in lymph node dissection, postoperative recovery, postoperative complications, and long-term survival.

Read the detailed description

Esophageal carcinoma is an aggressive malignancy with poor prognosis,For these patients, radical esophagectomy is the cornerstone of multimodality treatment with curative intent. Transthoracic esophagectomy is the preferred surgical approach worldwide allowing for en-bloc resection of the tumor. However, the percentage of cardiopulmonary complications associated with the traditional three-incision esophagectomy is high.Recent studies have shown that the minimally invasive thorascopic and laparoscopic esophagectomy is at least equivalent to the open transthoracic approach for esophageal cancer in terms of short-term oncological outcomes,including reduced blood loss, shorter ICU stay,and lower pulmonary complication rate, but the evidence is not ample because the sample size is not enough.The objective of this study is to compare the efficacy, perioperative complications, lymph node dissection and long term survival between the thoracic esophageal cancer patients treated by minimally invasive thorascopic/laparoscopic esophagectomy and open transthoracic esophagectomy by three incisions.

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Conditions studied

  • Esophageal Cancer
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In context

Esophageal Neoplasms

1,592 studies on the registry are indexed under Esophageal Neoplasms; 460 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 200 across 340 observational studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

Chinese Academy of Medical Sciences is the lead sponsor of 235 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

cT1b-3N0-1M0 thoracic esophageal cancer.

Inclusion criteria

  1. Patients with histologically proven squamous cell esophageal cancer, without any previous anti-tumor therapy;
  2. Preoperative clinical TNM stage:cT1b-3N0-1M0;
  3. Adequate cardiopulmonary, liver, brain and kidney function which can tolerate the esophagectomy either via traditional tree-incision or minimally invasive thorascopic/laparoscopic esophagectomy;
  4. Preoperative assessment by CT and EUS is fit for minimally invasive thorascopic/laparoscopic esophagectomy;
  5. Willing to participate the clinical trial and sign the informed consent before being enrolled into clinical trail.

Exclusion criteria

Exclusion Criteria:

  1. Previous use of anti-cancer therapy;
  2. Preoperative clinical TNM stage: N2-3 or M1;
  3. Inadequate cardiopulmonary,liver, brain and kidney function for surgery;
  4. Previous malignancy history;
  5. Unwilling to participate the clinical trial and refuse to sign informed consent.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Traditional open esophagectomy

    Treated by traditional three-incision esophagectomy in the centers with enough experience in esophagectomy via right thoracotomy and the volume ≧50 cases each year.

    Procedure: open esophagectomy

  • Minimally invasive eophagectomy

    treated by minimally invasive thorascopic/laparoscopic esophagectomy in the centers with enough experience in VATS esophagectomy and the volume≧50 cases each year.

    Procedure: Minimally invasive esophagectomy

Interventions

  • Procedureopen esophagectomy
  • ProcedureMinimally invasive esophagectomy
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What researchers measure

Primary outcomes

  1. Long term survival

    Time frame: 5 years

Secondary outcomes

  1. Disease free survival

    Time frame: 5 years

  2. Postoperative complications

    Time frame: 3 years

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Study locations

1 of 1 sites recruiting
  • Cancer hospital, Chinese Academy of Medical Sciences
    Beijing, Beijing 100021, China
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02448966
Lead sponsor
Chinese Academy of Medical Sciences
Collaborators
Peking University Cancer Hospital & Institute, Henan Cancer Hospital, Hebei Medical University Fourth Hospital, Shanghai Zhongshan Hospital, Harbin Medical University, Sichuan Cancer Hospital and Research Institute, Fujian Cancer Hospital, Liaoning Cancer Hospital & Institute, Hunan Cancer Hospital, Sun Yat-sen University, Zhejiang Cancer Hospital, Tang-Du Hospital, Shanghai Chest Hospital
Responsible party
Jie He (President, Chinese Academy of Medical Sciences) — Principal investigator
First posted
May 20, 2015
Start date
Jan 2015
Primary completion
Dec 2017 (estimated)
Completion
Dec 2019 (estimated)
Last update
May 20, 2015

Study contacts

Yousheng Mao, MD
Contact
maoysherx@126.com
8610-87787138
Zhirong Zhang, MD
Contact
zhangzr@cicams.ac.cn
8610-87788798
Jie He, MD,PhD
principal investigator · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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