Laparoscopy-assisted Pylorus-vagus Nerve Preserving Gastr... | NCT02936193

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

NCT02936193

Sponsor

RenJi Hospital

Status

Unknown status

Last Update Posted

Nov 5, 2019Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Early Gastric Cancer

Interventions

Pylorus preservation
Distal gastrectomy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2017Actual

Primary Completion Date

Nov 2, 2019Actual

Completion Date

Oct 2020Estimated

First Submitted Date

Oct 7, 2016

First Submission Date that Met QC Criteria

Oct 14, 2016

First Posted Date

Oct 18, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 3, 2019

Last Update Posted Date

Nov 5, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pylorus preservation	Experimental	Patients undergo Laparoscopic Gastrectomy with Pylorus-preservation	Procedure: Pylorus preservation
Distal gastrectomy	Active Comparator	Patients undergo Laparoscopic Gastrectomy procedure detailing in distal gastrectomy with D2 lymphadenectomy	Procedure: Distal gastrectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pylorus preservation	Procedure	Patients undergo Laparoscopic Gastrectomy featuring pylorus-preservation	Pylorus preservation

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

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

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ethics Committee of Renji Hospital, School of Medicine,Shanghai Jiaotong University	Recruiting	Shanghai	Shanghai Municipality	200127	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005763	Gastroenterostomy

Ancestor Terms

ID	Term
D000714	Anastomosis, Surgical
D013514	Surgical Procedures, Operative
D013505	Digestive System Surgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided