NCT02790333

Brief Summary

The purpose of this trial is to establish an objective criterion for assessing pancreatic stump texture, and unify stapler cartridge according to pancreatic stump texture and thickness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

May 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 31, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 3, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 8, 2021

Status Verified

January 1, 2021

Enrollment Period

1.6 years

First QC Date

May 31, 2016

Last Update Submit

January 6, 2021

Conditions

Pancreatic NeoplasmsPancreatic Fistula

Outcome Measures

Primary Outcomes (2)

  • Incidence of pancreatic fistula grade A/ B/C defined by ISGPF classification

    Pancreatic amylase concentration in any post operative drains. Fistula is diagnosed if pancreatic amylase \> 3 times the upper normal limit of pancreatic amylase in plasma on post operative day 3 or later

    Thirty days after operation

  • Pancreatic fibrosis accessed by histopathology and pancreatic stellate cell

    intraoperative

Secondary Outcomes (5)

  • Morbidity

    Thirty days after operation

  • Mortality

    Thirty days after operation

  • Time to oral intake

    Duration of hospital stay

  • Postoperative hospital stay

    Duration of hospital stay

  • Readmission rate

    Thirty days after operation

Study Arms (2)

Tri-Staple reloads

EXPERIMENTAL

Tri-Staple reloads were used for pancreatic stump texture

Procedure: Tri-Staple reloads

traditional reloads

ACTIVE COMPARATOR

the traditional reloads were used for pancreatic stump texture

Procedure: traditional reloads

Interventions

traditional reloadsPROCEDURE

Blue cartridge with3.0mm height staple was used for pancreatic stump

traditional reloads
Tri-Staple reloadsPROCEDURE

Purple cartridge with2.0-2.5-3.0mm varied-height staples was used for pancreatic stump

Tri-Staple reloads

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • disease of pancreatic body and tail
  • Age: 18 years or older
  • distant metastases are not diagnosed preoperatively.
  • Patients who can provide written informed consent

You may not qualify if:

  • Patients with severe organ disease such as cardiac disease,respiratory illness
  • Patients with pancreaticojejunostomy,pancreatogastrostomy
  • Patients with conversion to laparotomy
  • Patients with pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Provincial Peoples' Hospital

Hangzhou, Zhejiang, 310014, China

Location

MeSH Terms

Conditions

Pancreatic NeoplasmsPancreatic Fistula

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesDigestive System FistulaFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • YiPing Mou, MD

    Department of Gastrointestinal-Pancreatic Surgery, Zhejiang Provincial Peoples' Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD，Director

Study Record Dates

First Submitted

May 31, 2016

First Posted

June 3, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

January 8, 2021

Record last verified: 2021-01

Locations

CN(1)