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

Shanghai Jiao Tong University

Status: Unknown

Conditions: Early Gastric Cancer

Treatments: Procedure: Pylorus preservation; Procedure: Distal gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02936193

LAPPG

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Pylorus preservation

Experimental group

Description:

Patients undergo Laparoscopic Gastrectomy with Pylorus-preservation

Treatment:

Procedure: Pylorus preservation

Distal gastrectomy

Active Comparator group

Description:

Patients undergo Laparoscopic Gastrectomy procedure detailing in distal gastrectomy with D2 lymphadenectomy

Treatment:

Procedure: Distal gastrectomy