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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2020-10-31

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.

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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

Conditions

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Early Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pylorus preservation

Patients undergo Laparoscopic Gastrectomy with Pylorus-preservation

Group Type EXPERIMENTAL

Pylorus preservation

Intervention Type PROCEDURE

Patients undergo Laparoscopic Gastrectomy featuring pylorus-preservation

Distal gastrectomy

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

Group Type ACTIVE_COMPARATOR

Distal gastrectomy

Intervention Type PROCEDURE

Patients undergo laparoscopic gastrectomy in distal gastric resection with D2 lymphadenectomy

Interventions

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Pylorus preservation

Patients undergo Laparoscopic Gastrectomy featuring pylorus-preservation

Intervention Type PROCEDURE

Distal gastrectomy

Patients undergo laparoscopic gastrectomy in distal gastric resection with D2 lymphadenectomy

Intervention Type PROCEDURE

Other Intervention Names

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Laparoscopic-assisted pylorus preserving gastrectomy Laparoscopic-assisted distal gastrectomy

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes