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

Early Gastric Cancer Clinical Trial

— LAPPG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02936193
• Other study ID #: LAPPG
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: October 2020

Study information

• Verified date: April 2019
• Source: RenJi Hospital
• Contact: Lin Tu, MD
• Phone: 008618616547270
• Email: tl19870228[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2020
• Est. primary completion date: November 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Early Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Pylorus preservation
Patients undergo Laparoscopic Gastrectomy featuring pylorus-preservation
• Distal gastrectomy
Patients undergo laparoscopic gastrectomy in distal gastric resection with D2 lymphadenectomy

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postoperative complications		30 days
Secondary	Postoperative mortality		30 days
Secondary	3 years overall survival		3 years