Laparoscopic Versus Open Gastrectomy With Splenic Hilum Lymph Nodes Dissection

NCT ID: NCT02980861

Last Updated: 2016-12-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2020-06-30

Brief Summary

Splenic hilum remains challenging during total gastrectomy with D2 lymphadenectomy.The application of minimally invasive surgery for advanced gastric cancer is gaining popularity. The investigators aim to compare the safety and feasibility of LTG and OTG for advanced proximal gastric cancer.

Detailed Description

Total gastrectomy with D2 lymphadenectomy remains the standard surgical therapy for patients with advanced proximal gastric cancer. Although lymph nodes dissection along with the splenic hilum (No.10) is recommended by the Japanese Gastric Cancer Treatment Guidelines, however, complete removal of the No. 10 is technically challenging due to the tortuous splenic vessels and the high possibility of injury to the parenchyma of the spleen and pancreas. Recently, the application of minimally invasive surgery for advanced gastric cancer is gaining popularity. However, laparoscopic total gastrectomy (LTG) with standard D2 lymphadenectomy was still not widely performed, because pancreas- and spleen-preserving splenic hilum lymph node dissection were mainly challenging manipulations for laparoscopic surgeons. Therefore,the investigators aim to investigate the safety and feasibility of LTG with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer and compare the early results of this procedure with open total gastrectomy (OTG).

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laparoscopic total gastrectomy

Participants including in the laparoscopic total gastrectomy (LTG) group will undergo LTG with spleen-preserving splenic hilum lymph nodes dissection.

Group Type: EXPERIMENTAL

Laparoscopic total gastrectomy

Intervention Type: PROCEDURE

When the participants with advanced proximal gastric cancer are randomized in the laparoscopic totalgastrectomy (LATG) group, they will received LTG with spleen-preserving splenic hilum lymph nodes dissection.

Open total gastrectomy

Participants who are included in the open total gastrectomy (OTG) group will OTG with spleen-preserving splenic hilum lymph nodes dissection.

Group Type: ACTIVE_COMPARATOR

Open total gastrectomy

Intervention Type: PROCEDURE

When the participants with advanced proximal gastric cancer are randomized in the open total gastrectomy(OTG) group, they will received OTG with spleen-preserving splenic hilum lymph nodes dissection.

Interventions

Laparoscopic total gastrectomy

When the participants with advanced proximal gastric cancer are randomized in the laparoscopic totalgastrectomy (LATG) group, they will received LTG with spleen-preserving splenic hilum lymph nodes dissection.

Intervention Type: PROCEDURE

Open total gastrectomy

When the participants with advanced proximal gastric cancer are randomized in the open total gastrectomy(OTG) group, they will received OTG with spleen-preserving splenic hilum lymph nodes dissection.

Intervention Type: PROCEDURE

Other Intervention Names

LTG; OTG

Eligibility Criteria

Inclusion Criteria

1. Primary proximal gastric adenocarcinoma confirmed pathologically by endoscopic biopsy;

2. cT2-4aN0-3M0 at preoperative evaluation according to American Joint Committee On Cancer (AJCC) Cancer Staging Manual, 7th Edition.

3. Eastern Cooperative Oncology Group (ECOG): 0 or 1;

4. American Society of Anesthesiologists （ASA） score: Ⅰto Ⅲ;

5. Written informed consent.

Exclusion Criteria

1. Pregnant or breast-feeding women;

2. Severe mental disorder;

3. Previous upper abdominal surgery (except laparoscopic cholecystectomy);

4. Previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection;

5. Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging;

6. Other malignant disease within the past 5 years;

7. Previous neoadjuvant chemotherapy or radiotherapy;

8. Contraindication to general anesthesia (severe cardiac and/or pulmonary disease);

9. Emergency surgery due to a complication (bleeding, obstruction, or perforation) caused by gastric cancer.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lin Chen

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lin Chen

Role: PRINCIPAL_INVESTIGATOR

the Chinese PLA General Hospital

Locations

Chinese PLA General Hospital

Beijing, , China

Countries

China

Central Contacts

Hongqing Xi, Master

Role: CONTACT

010-66938128

Facility Contacts

Lin Chen, Master

Role: primary

chenlinbj@sina.com

86-13801290395

References

Bian S, Xi H, Wu X, Cui J, Ma L, Chen R, Wei B, Chen L. The Role of No. 10 Lymphadenectomy for Advanced Proximal Gastric Cancer Patients Without Metastasis to No. 4sa and No. 4sb Lymph Nodes. J Gastrointest Surg. 2016 Jul;20(7):1295-304. doi: 10.1007/s11605-016-3113-3. Epub 2016 Mar 3.

Reference Type: BACKGROUND

PMID: 26940944 (View on PubMed)

Guo X, Peng Z, Lv X, Cui J, Zhang K, Li J, Jin N, Xi H, Wei B, Chen L. Randomized controlled trial comparing short-term outcomes of laparoscopic and open spleen-preserving splenic hilar lymphadenectomy for advanced proximal gastric cancer: An interim report. J Surg Oncol. 2018 Dec;118(8):1264-1270. doi: 10.1002/jso.25262. Epub 2018 Oct 31.

Reference Type: DERIVED

PMID: 30380145 (View on PubMed)

Other Identifiers

Z161100000516237

Identifier Type: -

Identifier Source: org_study_id