Laparoscopy-assisted Pylorus-vagus Nerve Preserving Gastrectomy in the Treatment of Early Gastric Cancer

Not Applicable

• Conditions: Early Gastric Cancer
• Interventions: Procedure: Distal gastrectomy; Procedure: Pylorus preservation

• Registration Number: NCT02936193
• Lead Sponsor: RenJi Hospital

Brief Summary

The safety and efficacy of Laparoscopy-assisted Pylorus-preserving Gastrectomy (LAPPG) for the treatment of early gastric cancer (EGC) remain controversial. The investigators conducted a randomized controlled trial to compare LAPPG and laparoscopic distal gastrectomy with D2 lymph node dissections for EGC.

Detailed Description

During the procedure, the distal part of the stomach is resected, but a pyloric cuff 2-3 cm wide is preserved. The right gastric artery and the infrapyloric artery are preserved to maintain the blood supply to the pyloric cuff. In addition, the hepatic and pyloric branches of the vagal nerves are preserved to maintain pyloric function. The celiac branch of the posterior vagal trunk is sometimes preserved. All regional nodes except the suprapyloric nodes (No. 5) should be dissected as in the standard D2 procedure. However, there are technical challenges associated with completing all of these procedures.The five-year survival rate after PPG with modified D2 lymph node dissection ranges from 95% to 98%. This rate is comparable to the five-year survival rate after gastric resection for EGC, which ranges from 90% to 98%. In terms of oncologic safety, PPG seems reasonably safe for EGC when the accuracy of preoperative diagnosis can be assured

Study Timeline

• Study First Submitted: 2016-10-07
• Study First Submitted QC: 2016-10-14
• Study First Posted: 2016-10-18
• Study Start: 2017-08-01
• Status Verified: 2019-04
• Primary Completion: 2019-11-02
• Last Update Submitted: 2019-11-03
• Last Update Posted: 2019-11-05
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age older than 18 and younger than 75 years
• Primary gastric adenocarcinoma confirmed pathologically by endoscopic biopsy
• cT1-2N0-3M0 at preoperative evaluation according to AJCC Cancer Staging Manual, 7th Edition
• Expected curative resection via distal subtotal gastrectomy with D2 lymphadenectomy
• Written informed consent

Exclusion Criteria

• Pregnant or breast-feeding women
• Severe mental disorder
• Previous upper abdominal surgery (except laparoscopic cholecystectomy)
• Previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection
• Other malignant disease within the past 5 years
• Previous neoadjuvant chemotherapy or radiotherapy
• Unstable angina, myocardial infarction, or cerebrovascular accident within the past 6 months
• Continuous systematic administration of corticosteroids within 1 month before the study
• Requirement of simultaneous surgery for other diseases
• Emergency surgery due to a complication (bleeding, obstruction, or perforation) caused by gastric cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Distal gastrectomy	Distal gastrectomy	Patients undergo Laparoscopic Gastrectomy procedure detailing in distal gastrectomy with D2 lymphadenectomy
Pylorus preservation	Pylorus preservation	Patients undergo Laparoscopic Gastrectomy with Pylorus-preservation

Primary Outcome Measures

Name	Time	Method
Progression-free Survival	3 years	It is the time that passes from the first date after treatment and the date on which gastric cancer progresses, as demonstrated by laboratory testing, radiologic testing, or clinically.

Secondary Outcome Measures

Name	Time	Method
Postoperative mortality	30 days
Postoperative complications	30 days
3 years overall survival	3 years

Trial Locations

Locations (2)

Ethics Committee of Renji Hospital, School of Medicine, Shanghai Jiaotong University; 🇨🇳 Shanghai, China

Ethics Committee of Renji Hospital, School of Medicine,Shanghai Jiaotong University; 🇨🇳 Shanghai, Shanghai, China