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

Safety and Feasibility of Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Locally Advanced Upper Third Gastric Cancer: A Multicenter Phase II Trial

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02845986

Acronym

CLASS-04

Enrollment

251

Registered

2016-07-27

Start date

2016-09-01

Completion date

2020-10-12

Last updated

2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stomach Neoplasms

Keywords

Stomach Neoplasms, Laparoscopy, Spleen-Preserving, No.10 Lymph Node Dissection

Brief summary

The purpose of this study is to explore the safety and feasibility of the Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for patients with locally advanced upper third gastric adenocarcinoma（cT2-4a, N-/+, M0）.

Detailed description

Radical resection is still the primary method of treating advanced gastric cancer.According to the Japanese treatment guidelines for gastric cancer, D2 lymphadenectomy, including No. 10 lymph node dissection, should be adopted for upper third gastric carcinoma.The incidence of No. 10 lymph node metastasis is high in advanced proximal gastric cancer, reported to range from 9.8%-20.9%, and the presence of No. 10 lymph node metastasis is closely related to survival. Therefore, in East Asia, D2 lymph node dissection of potentially curable locally advanced upper third gastric cancer including No. 10 lymph node is the standard surgical treatment. In the early, splenectomy was performed to remove No. 10 lymph node. With the improvement of medical knowledge and surgical technique, spleen-preserving No. 10 lymph node dissection has been recognized by more and more surgeons. However, due to the special and complex anatomy of the spleen, spleen-preserving No. 10 lymph node dissection is difficult, even in open surgery; consequently, the surgery cannot be performed in many centers. Laparoscopic surgery has distinct minimally invasive advantages, such as small incisions, less blood loss, less postoperative pain, mild postoperative inflammatory reactions, a quick recovery of gastrointestinal function, shorter hospital stays and obvious cosmetic effects. Since Kitano et al. first reported laparoscopic gastrectomy for gastric cancer in 1994, laparoscopic techniques have developed rapidly. The techniques are becoming increasingly mature, making it possible to perform laparoscopic spleen-preserving No. 10 lymph node dissection. Our center first proposed Huang's three-step maneuver, a new operative method suitable for laparoscopic spleen-preserving No. 10 lymph node dissection. This method simplifies the procedure of laparoscopic spleen-preserving No. 10 lymph node dissection and facilitates its popularization and promotion. However, it remains a controversial international issue if it is safe and feasible to routinely conduct laparoscopic spleen-preserving No. 10 lymph node dissection for advanced upper third gastric cancer.A number of retrospective studies have successively confirmed the safety, feasibility and oncological efficacy of laparoscopic spleen-preserving No. 10 lymph node dissection.But there is no multicenter prospective studies to identify the results. Therefore, The study is through a prospective, multicenter, open, single-arm, non-inferiority study,to explore the safety and feasibility of the laparoscopic spleen-preserving No. 10 lymph node dissection for patients with locally advanced upper third gastric adenocarcinoma（cT2-4a, N-/+, M0）.

Interventions

PROCEDURELaparoscopic Spleen-Preserving No.10 Lymph Node Dissections

After exclusion of T4b, bulky lymph nodes, or distant metastasis case et al. Laparoscopic spleen-preserving No.10 lymph node dissections will be performed with curative treated intent in patients with locally advanced upper third gastric adenocarcinoma.

DRUGoxaliplatin

oxaliplatin or platinum-based chemotherapy is used when the patients undergo adjuvant chemotherapy after the surgery.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Age between 18 to 75 years old 2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy 3. Locally advanced tumor in the upper third stomach（cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC(American Joint Committee on Cancer) Cancer Staging Manual Seventh Edition） 4. No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations 5. Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale 6. ASA (American Society of Anesthesiology) class I to III 7. Written informed consent

Exclusion criteria

1. Pregnant and lactating women 2. Suffering from severe mental disorder 3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy) 4. History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer) 5. Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging including enlarged or bulky No.10 lymph node 6. History of other malignant disease within the past 5 years 7. History of previous neoadjuvant chemotherapy or radiotherapy 8. History of unstable angina or myocardial infarction within the past 6 months 9. History of cerebrovascular accident within the past 6 months 10. History of continuous systematic administration of corticosteroids within 1 month 11. Requirement of simultaneous surgery for other disease 12. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer 13. FEV1\<50% of the predicted values 14. Splenectomy must be performed due to the obvious tumor invasion in spleen or spleen blood vessels.

Design outcomes

Primary

Measure	Time frame	Description
overall postoperative morbidity rates	30 days	Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.

Secondary

Measure	Time frame	Description
Numbers of No.10 lymph node dissection	9 days	Numbers of dissected No.10 lymph nodes
Rates of positive No.10 lymph node	9 days	The Rates of positive No.10 lymph node are defined as the incidence of positive No.10 lymph node (divide number of positive No.10 lymph nodes by number of total No.10 lymph nodes).
3-year overall survival rate	36 months	—
3-year disease free survival rate	36 months	—
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.
Rates of splenectomy	1 days	The Rates of splenectomy are defined as the incidence of splenectomy within operation.
Intraoperative morbidity rates	1 days	The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
Time to first ambulation	30 days	Time to first ambulation in hours is used to assess the postoperative recovery course.
Time to first flatus	30 days	Time to first flatus in days is used to assess the postoperative recovery course.
Time to first liquid diet	30 days	Time to first liquid diet in days is used to assess the postoperative recovery course.
The variation of album	3, 6, 9 and 12 months	The variation of album in gram/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
Duration of postoperative hospital stay	30 days	Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
Postoperative pain	30 days	Visual analog pain score method is used to evaluate the difference of postoperative pain degree.The score of postoperative pain is used to assess the postoperative recovery course.
The variation of weight	3, 6, 9 and 12 months	The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
The variation of cholesterol	3, 6, 9 and 12 months	The variation of cholesterol in millimole/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
The results of endoscopy	3 and 12 months	The incidence of reflux esophagitis under the endoscopy on postoperative 3 and 12 months are used to access the postoperative quality of life.
The variation of body temperature	8 days	The daily highest body temperature in degree centigrade before discharge are recorded to access the inflammatory and immune response.
The variation of white blood cell count	Preoperative 3 days and postoperative 1, 3, and 5 days	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 variation of hemoglobin	Preoperative 3 days and postoperative 1, 3, and 5 days	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 variation of C-reactive protein	Preoperative 3 days and postoperative 1, 3, and 5 days	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 variation of prealbumin	Preoperative 3 days and postoperative 1, 3, and 5 days	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.
Time to first soft diet	30 days	Time to first soft diet in days is used to assess the postoperative recovery course.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026