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Status unknownNCT02936193LAPPGUpdated Nov 5, 2019

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

An interventional study of Pylorus preservation and Distal gastrectomy in Early Gastric Cancer, sponsored by RenJi Hospital. Status unknown at 2 sites in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-05.

Sponsored by RenJi Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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.

Read the 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

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Conditions studied

  • Early Gastric Cancer

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03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 100 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Pylorus preservation

    Patients undergo Laparoscopic Gastrectomy with Pylorus-preservation

    Procedure: Pylorus preservation

  • Active comparator
    Distal gastrectomy

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

    Procedure: Distal gastrectomy

Interventions

  • ProcedurePylorus preservation

    Patients undergo Laparoscopic Gastrectomy featuring pylorus-preservation

    Also known as: Laparoscopic-assisted pylorus preserving gastrectomy

  • ProcedureDistal gastrectomy

    Patients undergo laparoscopic gastrectomy in distal gastric resection with D2 lymphadenectomy

    Also known as: Laparoscopic-assisted distal gastrectomy

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 years

Secondary outcomes

  1. Postoperative complications

    Time frame: 30 days

  2. Postoperative mortality

    Time frame: 30 days

  3. 3 years overall survival

    Time frame: 3 years

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Study locations

2 of 2 sites recruiting
  • Ethics Committee of Renji Hospital, School of Medicine,Shanghai Jiaotong University
    Shanghai, Shanghai 200127, China
    Recruiting
  • Ethics Committee of Renji Hospital, School of Medicine, Shanghai Jiaotong University
    Shanghai, 200127, China
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02936193
Lead sponsor
RenJi Hospital
Responsible party
Sponsor
First posted
Oct 18, 2016
Start date
Aug 1, 2017
Primary completion
Nov 2, 2019
Completion
Oct 2020 (estimated)
Last update
Nov 5, 2019

Study contacts

Lin Tu, MD
Contact
tl19870228@hotmail.com
008618616547270
Gang Zhao, PhD
Contact
zhaogang74313@aliyun.com
0086-021-68383731

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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