NCT05856474

Brief Summary

The goal of this observational study is to learn about the type of surgical effect on pancreas transection. The main questions aims to answer are:

  • 1\. does pancreas preserving able to decrease incidence of postoperative diabeters
  • 2\. what is cause of major cause of postoperative morbidity and mortality in pancreas transection

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
45mo left

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress83%
Jan 2008Jan 2030

Study Start

First participant enrolled

January 1, 2008

Completed
15.3 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 12, 2023

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

May 12, 2023

Status Verified

April 1, 2023

Enrollment Period

22 years

First QC Date

May 3, 2023

Last Update Submit

May 3, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • post opereative diabetes

    occurence of diabetes following pancreas resection and pancreas preserving surgery

    6 month

Secondary Outcomes (1)

  • post removal drain outcome

    2 week to 4 weeks

Interventions

pancreaserving surgery, using end to side or end to end, pancreaticojejunostomy

Also known as: pancreaticojejunostomy

Eligibility Criteria

Age1 Year - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

hospital admission and underwent surgerical laparotomy in a single institution

You may qualify if:

  • Diagnosed to have pancreas injury confirmed to pancreas injury by laparotomy.

You may not qualify if:

  • negative pancreas injury by laparotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

RECRUITING

Related Publications (3)

  • Saisho Y, Butler AE, Meier JJ, Monchamp T, Allen-Auerbach M, Rizza RA, Butler PC. Pancreas volumes in humans from birth to age one hundred taking into account sex, obesity, and presence of type-2 diabetes. Clin Anat. 2007 Nov;20(8):933-42. doi: 10.1002/ca.20543.

  • Krige JE, Jonas E, Thomson SR, Kotze UK, Setshedi M, Navsaria PH, Nicol AJ. Resection of complex pancreatic injuries: Benchmarking postoperative complications using the Accordion classification. World J Gastrointest Surg. 2017 Mar 27;9(3):82-91. doi: 10.4240/wjgs.v9.i3.82.

  • Bozdag Z, Kapan M, Ulger BV, Turkoglu A, Uslukaya O, Oguz A, Aldemir M. Factors affecting morbidity and mortality in pancreatic injuries. Eur J Trauma Emerg Surg. 2016 Apr;42(2):231-5. doi: 10.1007/s00068-015-0526-8. Epub 2015 Apr 8.

MeSH Terms

Interventions

PancreatectomyPancreaticojejunostomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, OperativeAnastomosis, Surgical

Study Officials

  • Yen- Shen Shan

    National Cheng Kung University, College of Medicine

    STUDY CHAIR

Central Study Contacts

Chih-Jung Wang, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2023

First Posted

May 12, 2023

Study Start

January 1, 2008

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

May 12, 2023

Record last verified: 2023-04

Locations