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

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

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.

Study Overview

• Status: Unknown
• Conditions: Stomach Neoplasms
• Intervention / Treatment: Procedure: D2 lymphadenectomy including No. 10; Procedure: D2 lymphadenectomy excluding No. 10

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 Type: Interventional
• Enrollment (Anticipated): 536
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Fujian Medical University Union Hospital
      • Contact: Changming Huang, M.D., Ph.D.; Phone Number: +86-133-6591-0253; Email: hcmlr2002@163.com
      • Principal Investigator: Changming Huang, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
3-year disease free survival rate	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity and mortality	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.	30 days; 36 months
Time to first ambulation	The data of postoperative recovery course.	10 days
The variation of weight	The variation of weight on postoperative 3, 6, 9 and 12 months	12 months
The variation of cholesterol	The variation of cholesterol on postoperative 3, 6, 9 and 12 months	12 months
The variation of albumin	The variation of albumin on postoperative 3, 6, 9 and 12 months	12 months
The results of endoscopy	the results of endoscopy on postoperative 3 and 12 months	12 months
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
The values of hemoglobin	and the values of hemoglobin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.	7 days
The values of C-reactive protein	and the values of C-reactive protein from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.	7 days
The values of prealbumin	and the values of prealbumin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.	7 days
The values of relevant immune cytokines	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.	7 days
3-year overall survival rate	3-year overall survival rate	36 months
The daily highest body temperature	The daily highest body temperature before discharge	7 days
Intraoperative blood loss	Intraoperative blood loss	1 day
Rates of splenectomy	splenectomy performing by severe injury to the splenic vessels	1 day
Rates of injury to splenic vessels	intraoperative injury to the splenic vessels	1 day
The number of lymph node dissection	The total number of lymph node dissection and the number of lymph node dissection in each station	1 day
Time to first flatus	The time to first flatus	10 days
Time to first liquid diet	The time to first liquid diet	10 days
Time to soft diet	The time to soft diet	10 days
Duration of hospital stay	Duration of hospital stay	10 days
The amount of abdominal drainage	The amount of abdominal drainage	10 days
Blood transfusion	Perioperative blood transfusion	10 days
The number of positive lymph nodes	The number of positive lymph nodes	1 day
Intraoperative lymph node dissection time	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)	1 day
Intraoperative injury	Intraoperative injury	1 day
The amount of use of titanium clip	The amount of use of titanium clip	1 day
The rate of conversion to laparotomy	The rate of conversion to laparotomy	1 day
The values of white blood cell count	the values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.	7 days
The Surgery Task Load Index (SURG-TLX)	Surgeons were required to complete one modified SURG-TLX questionnaire for each procedure.	1 days
Lymph node noncompliance rate	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.	1 days
Technical performance	Technical performance were assessed by the Objective Structured Assessments of Technical Skills (OSATS) and the Generic Error Rating Tool.	1 days

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Lin JX, Lin JP, Wang ZK, Li P, Xie JW, Wang JB, Lu J, Chen QY, Cao LL, Lin M, Tu RH, Lin GT, Huang ZN, Lin JL, Zheng HL, Lin GS, Huang CM, Zheng CH. Assessment of Laparoscopic Spleen-Preserving Hilar Lymphadenectomy for Advanced Proximal Gastric Cancer Without Invasion Into the Greater Curvature: A Randomized Clinical Trial. JAMA Surg. 2023 Jan 1;158(1):10-18. doi: 10.1001/jamasurg.2022.5307.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: December 25, 2014
• First Submitted That Met QC Criteria: January 5, 2015
• First Posted (Estimate): January 7, 2015

Study Record Updates

• Last Update Posted (Actual): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 7, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Laparoscopy; Stomach Neoplasms
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: FUGES-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO