NCT02270554

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 21, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 21, 2016

Status Verified

July 1, 2016

Enrollment Period

1.8 years

First QC Date

October 10, 2014

Last Update Submit

July 20, 2016

Conditions

Pancreatic Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Incidence of pancreatic fistula grade B/C

    Ninety days after operation

Secondary Outcomes (12)

  • 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

  • Incidence of intraabdominal bleeding

    Ninety days after operation

  • Morbidity

    Ninety days after operation

  • Mortality

    Ninety days after operation

  • +7 more secondary outcomes

Study Arms (1)

Reinforced staple

EXPERIMENTAL

Endo GIA Reinforced Reload with Tri-Staple technology

Device: Endo GIA Reinforced Reload with Tri-Staple technology

Interventions

Endo GIA Reinforced Reload with Tri-Staple technologyDEVICE

Device:Endo GIA Reinforced Reload with Tri-Staple technology

Reinforced staple

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Kansai Rosai Hospital

Amagasaki, Hyogo, Japan

Location

Kansai Medical University

Hirakata, Osaka, Japan

Location

Hiroshima University

Hiroshima, Hiroshima, Japan

Location

Nara Medical University

Kashihara, Nara, Japan

Location

Kobe University

Kobe, Hyogo, Japan

Location

Kyoto Prefectural University of Medicine

Kyoto, Japan

Location

Nagoya University

Nagoya, Aichi, Japan

Location

Hyogo College of Medicine

Nishinomiya, Hyogo, Japan

Location

Osaka University

Osaka, Japan

Location

Kinki University

Sayama, Osaka, Japan

Location

Wakayama Medical University

Wakayama, 641-8510, Japan

Location

Related Publications (1)

  • 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.

    PMID: 29103084DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Hiroki Yamaue, M.D., Ph.D

    Wakayama Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Second Deaprtment of Surgery

Study Record Dates

First Submitted

October 10, 2014

First Posted

October 21, 2014

Study Start

October 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

July 21, 2016

Record last verified: 2016-07

Locations

JP(11)