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

Study Overview
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Brief Summary
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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
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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

Official Title
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Laparoscopy-assisted Pylorus-vagus Nerve Preserving Gastrectomy in the Treatment of Early Gastric Cancer: Clinical Outcomes of a Randomised Controlled Trial

Conditions
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Early Gastric Cancer

Intervention / Treatment
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* Procedure: Pylorus preservation
* Procedure: Distal gastrectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pylorus preservation<br>Patients undergo Laparoscopic Gastrectomy with Pylorus-preservation | Procedure: Pylorus preservation<br>* Patients undergo Laparoscopic Gastrectomy featuring pylorus-preservation<br>* Other names: Laparoscopic-assisted pylorus preserving gastrectomy;|
| Active Comparator: Distal gastrectomy<br>Patients undergo Laparoscopic Gastrectomy procedure detailing in distal gastrectomy with D2 lymphadenectomy | Procedure: Distal gastrectomy<br>* Patients undergo laparoscopic gastrectomy in distal gastric resection with D2 lymphadenectomy<br>* Other names: Laparoscopic-assisted distal gastrectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival | 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. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications |  | 30 days | 
| Postoperative mortality |  | 30 days | 
| 3 years overall survival |  | 3 years |