A Comparison Between Ivor-Lewis and McKeown Minimally Invasive Esophagectomy

• Sponsor: The Second Hospital of Shandong University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04217239
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 108
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

Surgery is still the main treatment for esophageal cancer, however, the complication and mortality rate of open esophagectomy is high. As a result, the thoracoscopic- laparoscopic minimally invasive esophagectomy (MIE) was developed. The MIE mainly comprised two surgical approaches:

MIE McKeown approach (cervical anastomosis) and MIE Ivor-Lewis approach (intrathoracicanastomosis). The MIE with intrathoracic anastomosis (Ivor-Lewis) is increasingly used for the treatment of mid and lower esophageal cancers. Our study is trying to compare the safety, feasibility, and short-term and long- term outcomes between MIE Ivor-Lewis approach and MIE McKeown approach for the treatment of lower thoracic esophageal cancer and esophageal- gastric junction.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer	Procedure: MIE Ivor- Lewis; Procedure: MIE McKeown	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Comparison of Short-term and Long- Term Outcomes Between Ivor-Lewis and McKeown Minimally Invasive Esophagectomy
• Actual Study Start Date: Jan 1, 2020
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ivor-Lewis group minimally invasive esophagectomy (MIE) with intrathoracic anastomosis	Procedure: MIE Ivor- Lewis; minimally invasive esophagectomy (MIE) with intrathoracic anastomosis
Active Comparator: McKeown group minimally invasive esophagectomy (MIE) with cervical anastomosis	Procedure: MIE McKeown; minimally invasive esophagectomy (MIE) with cervical anastomosis

Outcome Measures

Primary Outcome Measures

1. Operating time [1 day]

   Operating time in minutes

2. Blood loss [1 day]

   Blood loss in milliliter

3. Lymph nodes harvested [1 day]

   Lymph nodes harvested in number

4. Pulmonary complication [1 month]

   Pulmonary complication in rate

5. Anastomotic leakage [within one month]

   Anastomotic leakage in rate

6. Anastomotic stenosis [within three months]

   Anastomotic stenosis in rate

7. recurrent laryngeal nerve injury [within three months]

   recurrent laryngeal nerve injury in rate

8. Chylothorax [within one month]

   Chylothorax in rate

9. Cardiac arrhythmia [within one month]

   Cardiac arrhythmia in rate

10. Hospital stay [within 60 days]

    Hospital stay in days

11. mortality [within 90 days]

    mortality in rate

Secondary Outcome Measures

1. progression-free survival [within 5 years]

   progression-free survival in rate

2. overall survival [within 5 years]

   overall survival in rate

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

(I) Patients with clinically staged T1-3N0-2M0 tumors; good cardiopulmonary function;

(II) Patients with lower thoracic esophageal tumors and esophageal- gastric junction tumor;

(III) Patients without a previous history of cancer;

(IV) Patients without a previous history of neck or chest surgery;

Exclusion Criteria:

(I) cardiopulmonary function not good enough for surgery;

(II) Patients with hybrid MIE

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yunpeng Zhao	Jinan	Shandong	China	250033

Sponsors and Collaborators

• The Second Hospital of Shandong University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Second Hospital of Shandong University
• ClinicalTrials.gov Identifier: NCT04217239
• Other Study ID Numbers: MIE ZYP2
• First Posted: Jan 3, 2020
• Last Update Posted: Jan 3, 2020
• Last Verified: Jan 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The Second Hospital of Shandong University: Thoracoscopic; laparoscopic; esophagectomy

Study Results

No Results Posted as of Jan 3, 2020