Spleen-Preserving No. 10 Lymph Node Dissection in Gastric Cancer

Overall Survival Clinical Trial

Official title:

Study on Laparoscopic No. 10 Lymph Node Dissection With Preservation of Spleen for Advanced Middle or Upper Third Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04050787
• Other study ID #: No. 10 Lymph Node Dissection
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2019
• Est. completion date: May 2022

Study information

• Verified date: August 2019
• Source: First Hospital of Jilin University
• Contact: Jian Suo, Ph.D.
• Phone: ?181 8687 1293?
• Email: suojian0066[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to conduct a randomized controlled trial of two kinds of radical gastrectomy for patients with proximal gastric cancer. One is laparoscopic D2 radical total gastrectomy combined with spleen-preserving No.10 lymph node dissection , another one is laparoscopic D2 radical total gastrectomy without clearing the No. 10 lymph nodes of the spleen. We explore the effect of the two procedures on the survival of patients, as well as the surgical complications associated with the two procedures, the number of lymph node dissection, the operation time and the amount of intraoperative blood loss. Furthermore, we also want to discuss the application value of laparoscopic lymph node dissection for spleen preservation in radical gastrectomy for proximal gastric cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2022
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age from 18 to 80 years

2. Primary distal gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy

3. cT2-4a, N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition

4. No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.

5. Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)

6. American Society of Anesthesiology score (ASA) class I, II, or III

7. Written informed consent

Exclusion Criteria:

1. Women during pregnancy or breast-feeding

2. Severe mental disorder

3. History of previous upper abdominal surgery (except laparoscopic cholecystectomy)

4. History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection

5. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging

6. History of other malignant disease within past five years

7. History of previous neoadjuvant chemotherapy or radiotherapy

8. History of unstable angina or myocardial infarction within past six months

9. History of cerebrovascular accident within past six months

10. History of continuous systematic administration of corticosteroids within one month

11. Requirement of simultaneous surgery for other disease

12. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer

13. FEV1<50% of predicted values

Related Conditions & MeSH terms

• Overall Survival
• Stomach Neoplasms

Intervention

Procedure:
• D2 Lymphadenectomy including No. 10
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic total gastrectomy with D2 lymphadenectomy including spleen-Preserving No. 10 Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy
• D2 lymphadenectomy excluding No. 10
After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic total gastrectomy with D2 lymphadenectomy excluding spleen-Preserving No. 10 Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy

Locations

Country	Name	City	State
China	First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Jian Suo

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year disease free survival rate		36 months
Secondary	Morbidity	The early postoperative complication are defined as the event observed within 30 days after surgery, while the time frame for late complication is the period from postoperative day 31th to the end of month 36th.	30 days; 36 months
Secondary	3-year overall survival rate		36 months
Secondary	3-year recurrence pattern	Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type	36 months
Secondary	The number of lymph node dissection		1 day
Secondary	The number of positive lymph nodes		1 day