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Laparoscopic D2 lymphadenectomy plus CME will be performed for the treatment of patients assigned to this group.

Laparoscopic D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.

Laparoscopic D2 lymphadenectomy plus CME

Laparoscopic D2 lymphadenectomy

Jianping Gong, M.D.,Ph.D.

Radical gastrectomy for gastric cancer with D2 lymph node dissection has been widely applied in advanced gastric cancer. However,for most patients,tumor local-regional recurrence has been proven unavoidable.

Recently, many clinical studies have proved that some cancer cells and cancer nodes exist in the mesogastrium which can be hardly removed by conventional radical gastrectomy with D2 lymphadenectomy. It is suggested that Complete mesogastrium excision (CME) is imperative and should be added to D2 lymphadenectomy in order to reduce the risk of local recurrence.

Thus, the comparison of short-term and long-term outcome between laparoscopic D2 lymphadenectomy plus complete mesogastrium excision and conventional laparoscopic D2 lymphadenectomy for locally advanced gastric cancer based on a well designed randomized controlled trial is needed.

In this trial, patients and the follow-up staff are masked to the treatment allocation.

Study on Laparoscopic D2 Lymphadenectomy Plus Complete Mesogastrium Excision（D2+CME）for Advanced Gastric Cancer

Prospective Randomized Controlled Trial of Laparoscopic D2 Lymphadenectomy Plus Complete Mesogastrium Excision（D2+CME）vs. Laparoscopic D2 Lymphadenectomy for Advanced Gastric Cancer

Positive rate of cancer cells from intraperitoneal wash samples after gastrectomy

3-years disease-free survival of the enrolled patients

Time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay. The amount of abdominal drainage and blood transfusion are also recorded.

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 \[ Time Frame: 36 months \] \[ Designated as safety issue: No \]
* 3-year recurrence pattern \[ Time Frame: 36 months \] \[ Designated as safety issue: No \]

Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.

3-years overall survival of the enrolled patients

Huazhong University of Science and Technology

Director of Department of General Surgery

Laparoscopic D1 Lymphadenectomy will be performed for the treatment of patients assigned to this group.

Laparoscopic D2 Lymphadenectomy will be performed for the treatment of patients assigned to this group.

After exclusion of T4b, bulky lymph nodes, or distant metastasis case, laparoscopic D1 Lymphadenectomy will be performed in the experimental group.

Laparoscopic D1 Lymphadenectomy

After exclusion of T4b, bulky lymph nodes, or distant metastasis case, laparoscopic D2 Lymphadenectomy will be performed in the comparator group.

Laparoscopic D2 Lymphadenectomy

Changming Huang, Professor

The purpose of this study is to explore the clinical outcomes of laparoscopic D1 lymphadenectomy for elderly patients with advanced gastric adenocarcinoma（cT2-4a, N-/+, M0）

Gastrectomy with D2 lymphadenectomy is considered the gold standard treatment for advanced gastric cancer. However, some studies show that age or comorbidities is the relevant predictor of postoperative complications, conditioning the safety of the surgical procedure itself, thus affect the survial. Even with the advances in surgical techniques and care, age still is a significant risk for postoperative morbidity and mortality. Therefore, elderly patients with gastric cancer could receive minimally invasive surgery with reduced nodal dissection, i.e., D1 lymphadenectomy, in order to prevent postoperative complications. Laparoscopic surgery is a minimally invasive operation and is proved to be an acceptable alternative to open surgery. At present, there is no RCTs to confirm the safety and effectiveness of laparoscopic D1 lymphadenectomy for elderly patients with advanced gastric adenocarcinoma. This study is to compare the clinical outcomes of laparoscopic D1 versus D2 lymphadenectomy for elderly patients with advanced gastric adenocarcinoma（cT2-4a, N-/+, M0）to evaluate the safety of laparoscopic D1 lymphadenectomy, and to verify its results in terms of survival in elderly patients with advanced gastric adenocarcinoma.

Clinical Outcomes of Laparoscopic D1 Versus D2 Lymphadenectomy for Elderly Patients With Advanced Gastric Cancer

Randomized Controlled Trials Comparing Clinical Outcomes of Laparoscopic D1 Versus D2 Lymphadenectomy for Elderly Patients With Advanced Gastric Cancer

the rate of 3-year disease specific survival

Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.

Time to first ambulation in hours is used to assess the postoperative recovery course.

Time to first flatus in days is used to assess the postoperative recovery course.

Time to first liquid diet in days is used to assess the postoperative recovery course.

Time to first soft diet in days is used to assess the postoperative recovery course.

Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.

The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.

The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.

The values of C-reactive protein IN milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.

The values of prealbumin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.

Fujian Medical University

Director, Head of gastric surgery, Principal Investigator, Clinical Professor

Carcinoma

Laparoscopic bursectomy and D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.The key of this approach are that anterior lobe of transverse mesocolon and capsula pancreatis will be dissected with the D2 lymphadenectomy according to the guidelines of National Comprehensive Cancer Network(NCCN)

Laparoscopic D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.The key of this approach is that D2 lymphadenectomy is carried out according to the guidelines of National Comprehensive Cancer Network(NCCN) without dissociation of anterior lobe of transverse mesocolon and capsula pancreatis.

The anterior lobe of transverse mesocolon and capsula pancreatis will be dissected with the D2 lymphadenectomy according to the guidelines of National Comprehensive Cancer Network(NCCN) by laparoscopy，this is Laparoscopic bursectomy and D2 lymphadenectomy.

Laparoscopic bursectomy and D2 lymphadenectomy

D2 lymphadenectomy is carried out according to the guidelines of National Comprehensive Cancer Network(NCCN).

Jin Wan, professor

Liao-nan Zou, professor

liao-nan Zou, professor

xin-quan Lu, Dr

To investigate the clinical efficacy and safety of laparoscopic bursectomy and D2 lymphadenectomy (LBDL group) versus laparoscopic D2 lymphadenectomy (LDL group) in advanced gastric cancer by prospective randomized controlled clinical trial.

To compare the LBDL group and LDL group in the advanced gastric cancer. A prospective randomized controlled trial will be performed in the GI department, Guangdong provincial hospital of Chinese Medicine from November 2016 to November 2024. The sample size，100 cases with advanced gastric cancer, will be needed after calculated by the statistics. The 100 cases will be randomly divided into two groups: LBDL group and LDL group. Primary outcomes are the 3 years' Disease-free survival (DFS) rate, The secondary outcomes are the 3 years' and 5 years' Disease-free survival (DFS) rate, the 3 years and 5 years Overall survival（OS）rate, operative time, the total blood loss, the intra-operative complication and the post-operative complication, the number of lymph nodes dissected, the number of conversion to open laparotomy, and the other outcomes are the average time of ground activities, the hospital stay. The data in two groups will be compared.

Laparoscopic Bursectomy and D2 Lymphadenectomy vs.Laparoscopic D2 Lymphadenectomy in Advanced Gastric Cancer

Laparoscopic Bursectomy and D2 Lymphadenectomy vs.Laparoscopic D2 Lymphadenectomy in II,III Stage Gastric Carcinoma: A Prospective, Randomized, Single Blind, Parallel Group Clinical Trial

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study on Laparoscopic D2 Lymphadenectomy Plus Complete Mesogastrium Excision（D2+CME）for Advanced Gastric Cancer	NCT01978444	Gastric Cancer	Laparoscopic D2... Laparoscopic D2...	18 Years - 75 Years	Huazhong University of Science and Technology
Study on Laparoscopic D2 Lymphadenectomy Plus Complete Mesogastrium Excision（D2+CME）for Advanced Gastric Cancer	NCT01978444	Gastric Cancer	Laparoscopic D2... Laparoscopic D2...	18 Years - 75 Years	Huazhong University of Science and Technology
Clinical Outcomes of Laparoscopic D1 Versus D2 Lymphadenectomy for Elderly Patients With Advanced Gastric Cancer	NCT03290209	Stomach Neoplas...	Laparoscopic D1... Laparoscopic D2...	75 Years -	Fujian Medical University
Laparoscopic Bursectomy and D2 Lymphadenectomy vs.Laparoscopic D2 Lymphadenectomy in Advanced Gastric Cancer	NCT02969148	Gastric Cancer ... Gastric Cancer ...	Laparoscopic bu... Laparoscopic D2...	18 Years - 80 Years	Guangdong Provincial Hospital of Traditional Chinese Medicine

Spots Global Cancer Trial Database for laparoscopic d2 lymphadenectomy