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

Primary Purpose

Pancreatic Neoplasms

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Endo GIA Reinforced Reload with Tri-Staple technology
Sponsored by
Wakayama Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Neoplasms

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. disease of pancreatic body and tail
  2. PS (ECOG Performance Status Scale)0-1
  3. Age: 20 years or older
  4. 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
  5. Patients who can provide written informed consent

Exclusion Criteria:

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

Sites / Locations

  • Kansai Rosai Hospital
  • Kansai Medical University
  • Hiroshima University
  • Nara Medical University
  • Kobe University
  • Kyoto Prefectural University of Medicine
  • Nagoya University
  • Hyogo College of Medicine
  • Osaka University
  • Kinki University
  • Wakayama Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Reinforced staple

Arm Description

Endo GIA Reinforced Reload with Tri-Staple technology

Outcomes

Primary Outcome Measures

Incidence of pancreatic fistula grade B/C

Secondary Outcome Measures

Incidence of pancreatic fistula defined by ISGPF classification
Incidence of pancreatic fistula grade C defined by ISGPF classification
Incidence of intraabdominal bleeding
Morbidity
Mortality
Postoperative hospital stay
Hemostasis condition of staple line
Malformationof staple line Malformationof staple line Malformationof staple line Malformationof staple line Malformationof staple line
Period of drain insertion
Damage of pancreatic stump
Frequency of additional suture of pancreatic stump
Incidence of pancreatic fistula stratified based on thickness of pancreas parenchyma

Full Information

First Posted
October 10, 2014
Last Updated
July 20, 2016
Sponsor
Wakayama Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02270554
Brief Title
A Prospective, Multi-center Trial for Reinforced Staple During Distal Pancreatectomy
Official Title
A Prospective, Multi-center Investigation of Impact of the Endo GIA Reinforced Reload With Tri-Staple Technology During Distal Pancreatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wakayama Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reinforced staple
Arm Type
Experimental
Arm Description
Endo GIA Reinforced Reload with Tri-Staple technology
Intervention Type
Device
Intervention Name(s)
Endo GIA Reinforced Reload with Tri-Staple technology
Intervention Description
Device:Endo GIA Reinforced Reload with Tri-Staple technology
Primary Outcome Measure Information:
Title
Incidence of pancreatic fistula grade B/C
Time Frame
Ninety days after operation
Secondary Outcome Measure Information:
Title
Incidence of pancreatic fistula defined by ISGPF classification
Time Frame
Ninety days after operation
Title
Incidence of pancreatic fistula grade C defined by ISGPF classification
Time Frame
Ninety days after operation
Title
Incidence of intraabdominal bleeding
Time Frame
Ninety days after operation
Title
Morbidity
Time Frame
Ninety days after operation
Title
Mortality
Time Frame
Ninety days after operation
Title
Postoperative hospital stay
Time Frame
Ninety days after operation
Title
Hemostasis condition of staple line
Time Frame
during operation
Title
Malformationof staple line Malformationof staple line Malformationof staple line Malformationof staple line Malformationof staple line
Time Frame
during operation
Title
Period of drain insertion
Time Frame
Ninety days after operation
Title
Damage of pancreatic stump
Time Frame
during operation
Title
Frequency of additional suture of pancreatic stump
Time Frame
during operation
Title
Incidence of pancreatic fistula stratified based on thickness of pancreas parenchyma
Time Frame
Ninety days after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiroki Yamaue, M.D., Ph.D
Organizational Affiliation
Wakayama Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kansai Rosai Hospital
City
Amagasaki, Hyogo
Country
Japan
Facility Name
Kansai Medical University
City
Hirakata, Osaka
Country
Japan
Facility Name
Hiroshima University
City
Hiroshima, Hiroshima
Country
Japan
Facility Name
Nara Medical University
City
Kashihara, Nara
Country
Japan
Facility Name
Kobe University
City
Kobe, Hyogo
Country
Japan
Facility Name
Kyoto Prefectural University of Medicine
City
Kyoto
Country
Japan
Facility Name
Nagoya University
City
Nagoya, Aichi
Country
Japan
Facility Name
Hyogo College of Medicine
City
Nishinomiya, Hyogo
Country
Japan
Facility Name
Osaka University
City
Osaka
Country
Japan
Facility Name
Kinki University
City
Sayama, Osaka
Country
Japan
Facility Name
Wakayama Medical University
City
Wakayama
ZIP/Postal Code
641-8510
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
29103084
Citation
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.
Results Reference
derived

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

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