Back to results

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

Primary Purpose

Overall Survival

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

D2 Lymphadenectomy including No. 10

D2 lymphadenectomy excluding No. 10

About this trial

This is an interventional treatment trial for Overall Survival

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age from 18 to 80 years
Primary distal gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
cT2-4a, N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
American Society of Anesthesiology score (ASA) class I, II, or III
Written informed consent

Exclusion Criteria:

Women during pregnancy or breast-feeding
Severe mental disorder
History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
History of other malignant disease within past five years
History of previous neoadjuvant chemotherapy or radiotherapy
History of unstable angina or myocardial infarction within past six months
History of cerebrovascular accident within past six months
History of continuous systematic administration of corticosteroids within one month
Requirement of simultaneous surgery for other disease
Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
FEV1<50% of predicted values

Sites / Locations

First Hospital of Jilin UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

D2 Lymphadenectomy including No. 10

D2 lymphadenectomy excluding No. 10

Arm Description

lymphadenectomy including spleen-preserving No. 10 lymph node dissection will be performed for the treatment of patients assigned to this group

Laparoscopic total gastrectomy with D2 lymphadenectomy but without No. 10 lymph node dissection will be performed for the treatment of patients assigned to this group

Outcomes

Primary Outcome Measures

3-year disease free survival rate

Secondary Outcome Measures

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.

3-year overall survival rate

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

The number of lymph node dissection

The number of positive lymph nodes

Full Information

NCT ID

NCT04050787

First Posted

August 6, 2019

Last Updated

August 7, 2019

Sponsor

Jian Suo

1. Study Identification

Unique Protocol Identification Number

NCT04050787

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

July 21, 2019 (Actual)

Primary Completion Date

June 2021 (Anticipated)

Study Completion Date

May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jian Suo

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overall Survival

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

D2 Lymphadenectomy including No. 10

Arm Type

Experimental

Arm Description

lymphadenectomy including spleen-preserving No. 10 lymph node dissection will be performed for the treatment of patients assigned to this group

Arm Title

D2 lymphadenectomy excluding No. 10

Arm Type

Active Comparator

Arm Description

Laparoscopic total gastrectomy with D2 lymphadenectomy but without No. 10 lymph node dissection will be performed for the treatment of patients assigned to this group

Intervention Type

Procedure

Intervention Name(s)

D2 Lymphadenectomy including No. 10

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

D2 lymphadenectomy excluding No. 10

Intervention Description

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

Primary Outcome Measure Information:

Title

3-year disease free survival rate

Time Frame

36 months

Secondary Outcome Measure Information:

Title

Morbidity

Description

Time Frame

30 days; 36 months

Title

3-year overall survival rate

Time Frame

36 months

Title

3-year recurrence pattern

Description

Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type

Time Frame

36 months

Title

The number of lymph node dissection

Time Frame

1 day

Title

The number of positive lymph nodes

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age from 18 to 80 years Primary distal gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy cT2-4a, N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor. Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG) American Society of Anesthesiology score (ASA) class I, II, or III Written informed consent Exclusion Criteria: Women during pregnancy or breast-feeding Severe mental disorder History of previous upper abdominal surgery (except laparoscopic cholecystectomy) History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging History of other malignant disease within past five years History of previous neoadjuvant chemotherapy or radiotherapy History of unstable angina or myocardial infarction within past six months History of cerebrovascular accident within past six months History of continuous systematic administration of corticosteroids within one month Requirement of simultaneous surgery for other disease Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer FEV1<50% of predicted values

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jian Suo, Ph.D.

Phone

‭181 8687 1293‬

suojian0066@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yuchen Guo, Ph.D.

Phone

13630598312

guoyuchen8688@live.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jian Suo

Organizational Affiliation

Jilin University

Official's Role

Study Chair

Facility Information:

Facility Name

First Hospital of Jilin University

City

Changchun

State/Province

Jilin

ZIP/Postal Code

130021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jian Suo

Phone

‭181 8687 1293‬

suojian0066@126.com

First Name & Middle Initial & Last Name & Degree

Yuchen Guo

Phone

13630598312

guoyuchen8688@live.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs