LSPLN: Study on Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Advanced Middle or Upper Third Gastric Cancer

Sponsor

Fujian Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT02333721

Collaborator

(none)

536

Enrollment

Location

Arms

Anticipated Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to explore the short-term, long-term and oncological outcomes of laparoscopic spleen-preserving No. 10 lymph node dissection in a left-sided approach for advanced middle or upper third gastric cancer not invading greater curvature.

Condition or Disease	Intervention/Treatment	Phase
Stomach Neoplasms	Procedure: D2 lymphadenectomy including No. 10 Procedure: D2 lymphadenectomy excluding No. 10	N/A

Detailed Description

A prospective randomized comparison of laparoscopic spleen-preserving No. 10 lymph node dissection for gastric cancer will be performed, to evaluate the short-term, long-term and oncological outcomes. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

536 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Study on Long-term Outcome of Laparoscopic Spleen-Preserving D2 Lymphadenectomy With and Without No. 10 Lymph Node Dissection for Advanced Gastric Cancer

Actual Study Start Date :

Jan 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: D2 Lymphadenectomy including No. 10 Laparoscopic total gastrectomy with D2 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 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
Active Comparator: D2 lymphadenectomy excluding No. 10 Laparoscopic total gastrectomy with D2 lymphadenectomy excluding spleen-preserving No. 10 lymph node dissection will be performed for the treatment of patients assigned to this group	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

Arm

Intervention/Treatment

Experimental: D2 Lymphadenectomy including No. 10

Laparoscopic total gastrectomy with D2 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

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

Active Comparator: D2 lymphadenectomy excluding No. 10

Laparoscopic total gastrectomy with D2 lymphadenectomy excluding spleen-preserving No. 10 lymph node dissection will be performed for the treatment of patients assigned to this group

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

Outcome Measures

Primary Outcome Measures

3-year disease free survival rate [36 months]

Secondary Outcome Measures

Morbidity and mortality [30 days; 36 months]
The early postoperative complication and mortality 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 [36 months]
3-year overall survival rate
3-year recurrence pattern [36 months]
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type
Time to first ambulation [10 days]
The data of postoperative recovery course.
Rates of splenectomy [1 day]
splenectomy performing by severe injury to the splenic vessels
Rates of injury to splenic vessels [1 day]
intraoperative injury to the splenic vessels
The number of lymph node dissection [1 day]
The total number of lymph node dissection and the number of lymph node dissection in each station
The variation of weight [12 months]
The variation of weight on postoperative 3, 6, 9 and 12 months
The daily highest body temperature [7 days]
The daily highest body temperature before discharge
Time to first flatus [10 days]
The time to first flatus
Time to first liquid diet [10 days]
The time to first liquid diet
Time to soft diet [10 days]
The time to soft diet
Duration of hospital stay [10 days]
Duration of hospital stay
The amount of abdominal drainage [10 days]
The amount of abdominal drainage
Blood transfusion [10 days]
Perioperative blood transfusion
The number of positive lymph nodes [1 day]
The number of positive lymph nodes
Intraoperative lymph node dissection time [1 day]
intraoperative No.10 lymph node dissection time includes infrapyloric area lymph node,suprapancreatic area lymph node,splenic hilar area lymph node, cardial area lymph node)
Intraoperative blood loss [1 day]
Intraoperative blood loss
Intraoperative injury [1 day]
Intraoperative injury
The amount of use of titanium clip [1 day]
The amount of use of titanium clip
The rate of conversion to laparotomy [1 day]
The rate of conversion to laparotomy
The variation of cholesterol [12 months]
The variation of cholesterol on postoperative 3, 6, 9 and 12 months
The variation of albumin [12 months]
The variation of albumin on postoperative 3, 6, 9 and 12 months
The results of endoscopy [12 months]
the results of endoscopy on postoperative 3 and 12 months
The values of white blood cell count [7 days]
the values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
The values of hemoglobin [7 days]
and the values of hemoglobin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
The values of C-reactive protein [7 days]
and the values of C-reactive protein from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
The values of prealbumin [7 days]
and the values of prealbumin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
The values of relevant immune cytokines [7 days]
and the values of relevant immune cytokines including T cell percentage, T-helper lymphocytes (CD4+) percentage, T-suppressor lymphocytes (CD8+) percentage, natural killer (NK) cells percentage from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
The Surgery Task Load Index (SURG-TLX) [1 days]
Surgeons were required to complete one modified SURG-TLX questionnaire for each procedure.
Lymph node noncompliance rate [1 days]
Lymph node noncompliance was defined as the absence of lymph nodes that should have been excised from more than 1 lymph node station. Major lymph node noncompliance was defined as more than 2 intended lymph node stations that were not removed.
Technical performance [1 days]
Technical performance were assessed by the Objective Structured Assessments of Technical Skills (OSATS) and the Generic Error Rating Tool.

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age from 18 to 75 years
Primary proximal gastric adenocarcinoma not invading greater curvature (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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fujian Medical University Union Hospital	Fuzhou	Fujian	China	350001

Sponsors and Collaborators

Fujian Medical University

Investigators

Study Chair: Changming Huang, M.D.,Ph.D., Fujian Medical University Union Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chang-Ming Huang, Prof., Director, Principal Investigator, Clinical Professor, Fujian Medical University Union Hospital

ClinicalTrials.gov Identifier:

NCT02333721

Other Study ID Numbers:

FUGES-002

First Posted:

Jan 7, 2015

Last Update Posted:

Sep 9, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Chang-Ming Huang, Prof., Director, Principal Investigator, Clinical Professor, Fujian Medical University Union Hospital

Stomach Neoplasms

Laparoscopy

Additional relevant MeSH terms:

Stomach Neoplasms

Study Results

No Results Posted as of Sep 9, 2020