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

NCT04050787 | Unknown

• 1 other identifier: No. 10 Lymph Node Dissection
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Overall Survival

Outcome Measures

Primary Outcomes (1)

• 3-year disease free survival rate

  36 months

Secondary Outcomes (5)

• Morbidity

  30 days; 36 months

• 3-year overall survival rate

  36 months

• 3-year recurrence pattern

  36 months

• The number of lymph node dissection

  1 day

• The number of positive lymph nodes

  1 day

Study Arms (2)

D2 Lymphadenectomy including No. 10

EXPERIMENTAL

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

Procedure: D2 Lymphadenectomy including No. 10

D2 lymphadenectomy excluding No. 10

ACTIVE COMPARATOR

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

Procedure: D2 lymphadenectomy excluding No. 10

Interventions

D2 Lymphadenectomy including No. 10 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 including No. 10

D2 lymphadenectomy excluding No. 10 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

D2 lymphadenectomy excluding No. 10

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jian Suo: lead

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

Study Officials

• Jian Suo

  Jilin University

  STUDY CHAIR

Central Study Contacts

Jian Suo, Ph.D.

CONTACT

‭181 8687 1293‬; suojian0066@126.com

Yuchen Guo, Ph.D.

CONTACT

13630598312; guoyuchen8688@live.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 8, 2019
• Study Start: July 21, 2019
• Primary Completion: June 1, 2021
• Study Completion: May 1, 2022
• Last Updated: August 8, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)