Clinical trial NCT02333721: Study on Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Advanced Middle or Upper Third Gastric Cancer
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
Overall status: UNKNOWN
Phase: NA
Conditions: Stomach Neoplasms
Keywords: Stomach Neoplasms
Laparoscopy
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2015-01-07
Enrollment: 536
Sex: ALL
Minimum age (years): 10
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 3-year disease free survival rate
timeFrame: 36 months
Secondary outcomes:
measure: Morbidity and mortality
timeFrame: 30 days; 36 months
measure: 3-year overall survival rate
timeFrame: 36 months
measure: 3-year recurrence pattern
timeFrame: 36 months
measure: Time to first ambulation
timeFrame: 10 days
measure: Rates of splenectomy
timeFrame: 1 day
measure: Rates of injury to splenic vessels
timeFrame: 1 day
measure: The number of lymph node dissection
timeFrame: 1 day
measure: The variation of weight
timeFrame: 12 months
measure: The daily highest body temperature
timeFrame: 7 days
measure: Time to first flatus
timeFrame: 10 days
measure: Time to first liquid diet
timeFrame: 10 days
measure: Time to soft diet
timeFrame: 10 days
measure: Duration of hospital stay
timeFrame: 10 days
measure: The amount of abdominal drainage
timeFrame: 10 days
measure: Blood transfusion
timeFrame: 10 days
measure: The number of positive lymph nodes
timeFrame: 1 day
measure: Intraoperative lymph node dissection time
timeFrame: 1 day
measure: Intraoperative blood loss
timeFrame: 1 day
measure: Intraoperative injury
timeFrame: 1 day
measure: The amount of use of titanium clip
timeFrame: 1 day
measure: The rate of conversion to laparotomy
timeFrame: 1 day
measure: The variation of cholesterol
timeFrame: 12 months
measure: The variation of albumin
timeFrame: 12 months
measure: The results of endoscopy
timeFrame: 12 months
measure: The values of white blood cell count
timeFrame: 7 days
measure: The values of hemoglobin
timeFrame: 7 days
measure: The values of C-reactive protein
timeFrame: 7 days
measure: The values of prealbumin
timeFrame: 7 days
measure: The values of relevant immune cytokines
timeFrame: 7 days
measure: The Surgery Task Load Index (SURG-TLX)
timeFrame: 1 days
measure: Lymph node noncompliance rate
timeFrame: 1 days
measure: Technical performance
timeFrame: 1 days
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Changming Huang, M.D.,Ph.D.
role: STUDY_CHAIR
References:
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.