Clinical trial NCT02936193: Laparoscopy-assisted Pylorus-vagus Nerve Preserving Gastrectomy in the Treatment of Early Gastric Cancer
Official title: Laparoscopy-assisted Pylorus-vagus Nerve Preserving Gastrectomy in the Treatment of Early Gastric Cancer: Clinical Outcomes of a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Early Gastric Cancer
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Progression-free Survival
timeFrame: 3 years
Secondary outcomes:
measure: Postoperative complications
timeFrame: 30 days
measure: Postoperative mortality
timeFrame: 30 days
measure: 3 years overall survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ethics Committee of Renji Hospital, School of Medicine,Shanghai Jiaotong University
state: Shanghai
city: Shanghai
country: China
facility: Ethics Committee of Renji Hospital, School of Medicine, Shanghai Jiaotong University
Study officials:
References: