A Prospective, Multi-center Trial for Reinforced Staple D... | NCT02270554

Studies
A Prospective, Multi-center Trial for Reinforced Staple During Distal Pancreatectomy

NCT02270554

Sponsor

Wakayama Medical University

Status

Completed

Last Update Posted

Jul 21, 2016Estimated

Enrollment

120Actual

Phase

Phase 2

Conditions

Pancreatic Neoplasms

Interventions

Endo GIA Reinforced Reload with Tri-Staple technology

Countries

Japan

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

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Jul 2016Actual

Completion Date

Jul 2016Actual

First Submitted Date

Oct 10, 2014

First Submission Date that Met QC Criteria

Oct 16, 2014

First Posted Date

Oct 21, 2014Estimated

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

Jul 20, 2016

Last Update Posted Date

Jul 21, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hiroki Yamaue, Second Deaprtment of Surgery, Wakayama Medical UniversityPrincipal Investigator

Lead Sponsor

Wakayama Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 aim of this study is to evaluate if the Endo GIA Reinforced Reload with Tri-Staple Technology reduce incidence of pancreatic fistula (ISGPF grade B and C) after distal pancreatectomy by a prospective, multi-center trial.

Detailed Description

Reducing the incidence of pancreatic fistula is the most important issue in pancreatectomy. There is no certain view on the pancreatic resection method to reduce pancreatic fistula in distal pancreatectomy.This study will be conducted to scientifically investigate the impact of Endo GIA Reinforced Reload with Tri-Staple Technology in distal pancreatectomy. The aim of this study is to evaluate if the Endo GIA Reinforced Reload with Tri-Staple Technology reduce incidence of pancreatic fistula (ISGPF grade B and C) after distal pancreatectomy by a prospective, multi-center trial.

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Reinforced staple	Experimental	Endo GIA Reinforced Reload with Tri-Staple technology	Device: Endo GIA Reinforced Reload with Tri-Staple technology

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endo GIA Reinforced Reload with Tri-Staple technology	Device	Device:Endo GIA Reinforced Reload with Tri-Staple technology	Reinforced staple

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of pancreatic fistula grade B/C		Ninety days after operation

Secondary Outcomes

Measure	Description	Time Frame
Incidence of pancreatic fistula defined by ISGPF classification		Ninety days after operation
Incidence of pancreatic fistula grade C defined by ISGPF classification		Ninety days after operation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

disease of pancreatic body and tail
PS (ECOG Performance Status Scale)0-1
Age: 20 years or older
distant metastases are not diagnosed preoperatively. Eligible for this clinical study when only distal pancreatectomy contributes to the favorable prognosis even if patients with pancreatic neuroendocrine cancer have the liver metastasis
Patients who can provide written informed consent

Exclusion Criteria:

Patients with severe ischemic cardiac disease
Patients with severe liver cirrhosis or active hepatitis
Patients with respiratory illness that requires oxygen administration
Patients with chronic renal failure requiring dialysis
Patients requiring other organ resection
Patients who are unfit for the study as determined by the attending physician

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hiroki Yamaue, M.D., Ph.D	Wakayama Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kansai Rosai Hospital		Amagasaki, Hyogo			Japan
Kansai Medical University

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29103084	Derived	Kawai M, Hirono S, Okada KI, Satoi S, Yanagimoto H, Kon M, Murakami Y, Kondo N, Sho M, Akahori T, Toyama H, Fukumoto T, Fujii T, Matsumoto I, Eguchi H, Ikoma H, Takeda Y, Fujimoto J, Yamaue H. Reinforced staplers for distal pancreatectomy. Langenbecks Arch Surg. 2017 Dec;402(8):1197-1204. doi: 10.1007/s00423-017-1634-1. Epub 2017 Nov 4.

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms