search
Back to results

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

Primary Purpose

Stomach Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
D2 lymphadenectomy including No. 10
D2 lymphadenectomy excluding No. 10
Sponsored by
Fujian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasms focused on measuring Stomach Neoplasms, Laparoscopy

Eligibility Criteria

10 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Fujian Medical University Union HospitalRecruiting

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

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

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

Outcomes

Primary Outcome Measures

3-year disease free survival rate

Secondary Outcome Measures

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.
3-year overall survival rate
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
Time to first ambulation
The data of postoperative recovery course.
Rates of splenectomy
splenectomy performing by severe injury to the splenic vessels
Rates of injury to splenic vessels
intraoperative injury to the splenic vessels
The number of lymph node dissection
The total number of lymph node dissection and the number of lymph node dissection in each station
The variation of weight
The variation of weight on postoperative 3, 6, 9 and 12 months
The daily highest body temperature
The daily highest body temperature before discharge
Time to first flatus
The time to first flatus
Time to first liquid diet
The time to first liquid diet
Time to soft diet
The time to soft diet
Duration of hospital stay
Duration of hospital stay
The amount of abdominal drainage
The amount of abdominal drainage
Blood transfusion
Perioperative blood transfusion
The number of positive lymph nodes
The number of positive lymph nodes
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)
Intraoperative blood loss
Intraoperative blood loss
Intraoperative injury
Intraoperative injury
The amount of use of titanium clip
The amount of use of titanium clip
The rate of conversion to laparotomy
The rate of conversion to laparotomy
The variation of cholesterol
The variation of cholesterol on postoperative 3, 6, 9 and 12 months
The variation of albumin
The variation of albumin on postoperative 3, 6, 9 and 12 months
The results of endoscopy
the results of endoscopy on postoperative 3 and 12 months
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.
The values of hemoglobin
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
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
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
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)
Surgeons were required to complete one modified SURG-TLX questionnaire for each procedure.
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.
Technical performance
Technical performance were assessed by the Objective Structured Assessments of Technical Skills (OSATS) and the Generic Error Rating Tool.

Full Information

First Posted
December 25, 2014
Last Updated
September 7, 2020
Sponsor
Fujian Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT02333721
Brief Title
Study on Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Advanced Middle or Upper Third Gastric Cancer
Acronym
LSPLN
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fujian Medical University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms
Keywords
Stomach Neoplasms, Laparoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
536 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
D2 Lymphadenectomy including No. 10
Arm Type
Experimental
Arm Description
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
Arm Title
D2 lymphadenectomy excluding No. 10
Arm Type
Active Comparator
Arm Description
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
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 and mortality
Description
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.
Time Frame
30 days; 36 months
Title
3-year overall survival rate
Description
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
Time to first ambulation
Description
The data of postoperative recovery course.
Time Frame
10 days
Title
Rates of splenectomy
Description
splenectomy performing by severe injury to the splenic vessels
Time Frame
1 day
Title
Rates of injury to splenic vessels
Description
intraoperative injury to the splenic vessels
Time Frame
1 day
Title
The number of lymph node dissection
Description
The total number of lymph node dissection and the number of lymph node dissection in each station
Time Frame
1 day
Title
The variation of weight
Description
The variation of weight on postoperative 3, 6, 9 and 12 months
Time Frame
12 months
Title
The daily highest body temperature
Description
The daily highest body temperature before discharge
Time Frame
7 days
Title
Time to first flatus
Description
The time to first flatus
Time Frame
10 days
Title
Time to first liquid diet
Description
The time to first liquid diet
Time Frame
10 days
Title
Time to soft diet
Description
The time to soft diet
Time Frame
10 days
Title
Duration of hospital stay
Description
Duration of hospital stay
Time Frame
10 days
Title
The amount of abdominal drainage
Description
The amount of abdominal drainage
Time Frame
10 days
Title
Blood transfusion
Description
Perioperative blood transfusion
Time Frame
10 days
Title
The number of positive lymph nodes
Description
The number of positive lymph nodes
Time Frame
1 day
Title
Intraoperative lymph node dissection time
Description
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)
Time Frame
1 day
Title
Intraoperative blood loss
Description
Intraoperative blood loss
Time Frame
1 day
Title
Intraoperative injury
Description
Intraoperative injury
Time Frame
1 day
Title
The amount of use of titanium clip
Description
The amount of use of titanium clip
Time Frame
1 day
Title
The rate of conversion to laparotomy
Description
The rate of conversion to laparotomy
Time Frame
1 day
Title
The variation of cholesterol
Description
The variation of cholesterol on postoperative 3, 6, 9 and 12 months
Time Frame
12 months
Title
The variation of albumin
Description
The variation of albumin on postoperative 3, 6, 9 and 12 months
Time Frame
12 months
Title
The results of endoscopy
Description
the results of endoscopy on postoperative 3 and 12 months
Time Frame
12 months
Title
The values of white blood cell count
Description
the values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
Time Frame
7 days
Title
The values of hemoglobin
Description
and the values of hemoglobin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
Time Frame
7 days
Title
The values of C-reactive protein
Description
and the values of C-reactive protein from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
Time Frame
7 days
Title
The values of prealbumin
Description
and the values of prealbumin from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.
Time Frame
7 days
Title
The values of relevant immune cytokines
Description
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.
Time Frame
7 days
Title
The Surgery Task Load Index (SURG-TLX)
Description
Surgeons were required to complete one modified SURG-TLX questionnaire for each procedure.
Time Frame
1 days
Title
Lymph node noncompliance rate
Description
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.
Time Frame
1 days
Title
Technical performance
Description
Technical performance were assessed by the Objective Structured Assessments of Technical Skills (OSATS) and the Generic Error Rating Tool.
Time Frame
1 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Changming Huang, M.D., Ph.D.
Phone
+86-138-0506-9676
Email
hcmlr2002@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qiyue Chen, M.D.
Phone
+86-159-8023-5636
Email
690934662@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changming Huang, M.D.,Ph.D.
Organizational Affiliation
Fujian Medical University Union Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changming Huang, M.D., Ph.D.
Phone
+86-133-6591-0253
Email
hcmlr2002@163.com
First Name & Middle Initial & Last Name & Degree
Changming Huang, M.D., Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36383362
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs