Esophagectomy in Middle and Lower Thoracic Esophageal Cancer Patients Through Left Versus Right Transthoracic Approach

NCT ID: NCT02448979

Last Updated: 2015-05-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2019-12-31

Brief Summary

Esophageal carcinoma is an aggressive malignant disease with poor prognosis. Surgical resection remains the most effective method for this malignancy. Although different approaches have been studied for the surgical resection of thoracic esophageal cancer, little evidence has been achieved due to lack of large scale multicenter randomized trials with regard to this issue: whether left transthoracic approach or right transthoracic approach is the optimal surgical approach for treating middle and lower thoracic esophageal cancer without upper mediastinal lymph node metastasis. The purpose of this study is to compare the postoperative local recurrence rate and long-term outcome of esophagectomy through left and right transthoracic approach in the middle and lower thoracic esophageal cancer patients without preoperative upper mediastinal lymph node metastasis.

Detailed Description

Esophageal carcinoma is an aggressive malignant disease with poor prognosis. Surgical resection remains the most effective method for this malignancy. As to the middle and lower thoracic esophageal cancer patients without upper mediastinal lymph node metastasis, the rational transthoracic approach either through right or left chest has not been clarified to date due to lack of large scale multicenter randomized trials. Although some randomized trials had been finished in single-center, there is no enough evidences that all lower and middle thoracic esophageal cancer patients should be surgically treated throuhg right chest approch. It is widely recognized that left thoracotomy approach(Sweet procedure) is not appropriate in the patients with upper mediastinal lymph node metastasis, because patients can benefit from the right thoracotomy approach, through which upper mediastinal lymph node can be dissected completely and may get a better long-term survival.Therefore,in this study, the enrolled patients are the middle and lower thoracic esophageal cancer patients without preoperative upper mediastinal lymph node metastasis by CT and/or ultrasound, and 10 hospitals will participate this study. Through comparison in postoperative complications and long term outcomes as well as locoregional recurrence between the left and right apppoach, hopefully we can answer the question whether the right or left transthoracic procedure is the optimal approach for treating middle and lower thoracic esophageal cancer patients without preoperative upper mediastinal lymph node metastasis.

Conditions

Esophageal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Left thoracotomy

Esophagectomy through left side transthoracic approach, with esophagogastric anastomosis above aortic arch and two-field lymphadenectomy (thoracic and abdominal lymph node)

Group Type: ACTIVE_COMPARATOR

Left thoracotomy

Intervention Type: PROCEDURE

Transthoracic approach is the surgical procedure including the open and minimally invasive thoracotomy.

Right thoracotomy

Esophagectomy through right side transthoracic approach, with esophagogastric anastomosis above azygos vain arch or on the top of chest cavity and two-field lymphadenectomy (thoracic and abdominal lymph node)

Group Type: ACTIVE_COMPARATOR

Right thoracotomy

Intervention Type: PROCEDURE

Transthoracic approach is the surgical procedure including the open and minimally invasive thoracotomy.

Interventions

Left thoracotomy

Transthoracic approach is the surgical procedure including the open and minimally invasive thoracotomy.

Intervention Type: PROCEDURE

Right thoracotomy

Transthoracic approach is the surgical procedure including the open and minimally invasive thoracotomy.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Patients with histologically proved squamous cell esophageal cancer without any previous anti-tumor therapy;

2. The preoperative clinical TNM stage: cT1b-3N0-1M0;

3. Adequate function of heart, lung, liver, brain and kidney, which can tolerate esophagectomy either through left or right thoracotomy;

4. Without any preoperative distant metastases confirmed by preoperative examination such as chest and abdominal CT, brain MRI and bone scan or PET-CT;

5. No evidence showing suspicious upper mediastinal lymph node metastasis (short diameter of LN <0.8cm or shortest diameter / longest diameter <0.65) by the thoracic and abdominal CT and endoscopic ultrasonography(EUS).

6. Willing to participate the clinical trial and sign informed consent before being enrolled into clinical trail.

Exclusion Criteria

1. Non-squamous cell esophageal carcinoma or has any previous anti-cancer therapy before surgery;

2. The preoperative clinical TNM stage reaches: N2-3 or M1;

3. Inadequate cardiopulmonary, liver, brain and kidney function for tolerating the esophagectomy ;

4. Previous history of malignancy;

5. Unwilling to participate the clinical trial and refuse to sign informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: collaborator

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: collaborator

Hebei Medical University Fourth Hospital

OTHER

Sponsor Role: collaborator

Harbin Medical University

OTHER

Sponsor Role: collaborator

Liaoning Cancer Hospital & Institute

OTHER

Sponsor Role: collaborator

Hunan Cancer Hospital

OTHER

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: collaborator

Zhejiang Cancer Hospital

OTHER

Sponsor Role: collaborator

Tongji Hospital

OTHER

Sponsor Role: collaborator

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Jie He

President

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cancer hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Yousheng Mao, MD

Role: primary

maoysherx@126.com

8610-87787138

Zhirong Zhang, MD

Role: backup

zhangzr@cicams.ac.cn

8610-87788798

References

Mao YS, Gao SG, Li Y, Hao AL, Liu JF, Li XF, Rong TH, Fu JH, Ma JQ, Xu MQ, Zhang RQ, Xiao GM, Fu XN, Chen KN, Mao WM, Liu YY, Liu HX, Zhang ZR, Fang Y, Fu DH, Wei XD, Yuan LG, Muhammad S, Wei WQ, Chiu PW, Lloyd S, Schlottmann F, Meredith K, Pimiento JM, Gao YB, He J. Efficacy and safety of esophagectomy via left thoracic approach versus via right thoracic approach for middle and lower thoracic esophageal cancer: a multicenter randomized clinical trial (NST1501). Ann Transl Med. 2022 Aug;10(16):904. doi: 10.21037/atm-22-3810.

Reference Type: DERIVED

PMID: 36111056 (View on PubMed)

Other Identifiers

NKTRDP-2015BAI12B08-01

Identifier Type: -

Identifier Source: org_study_id