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

NCT ID: NCT04050787

Last Updated: 2019-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-21

Study Completion Date

2022-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Overall Survival

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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D2 Lymphadenectomy including No. 10

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

Group Type EXPERIMENTAL

D2 Lymphadenectomy including No. 10

Intervention Type PROCEDURE

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

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

Group Type ACTIVE_COMPARATOR

D2 lymphadenectomy excluding No. 10

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jian Suo

OTHER

Sponsor Role lead

Responsible Party

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Jian Suo

professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jian Suo

Role: STUDY_CHAIR

Jilin University

Locations

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First Hospital of Jilin University

Changchun, Jilin, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jian Suo, Ph.D.

Role: CONTACT

‭181 8687 1293‬

Yuchen Guo, Ph.D.

Role: CONTACT

13630598312

Facility Contacts

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Jian Suo

Role: primary

‭181 8687 1293‬

Yuchen Guo

Role: backup

13630598312

Other Identifiers

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No. 10 Lymph Node Dissection

Identifier Type: -

Identifier Source: org_study_id

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