Management of Traumatic Pancreas Transection

Surgical Management of Traumatic Pancreas Transection

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

Study Overview

• Status: Recruiting
• Conditions: Pancreatectomy
• Intervention / Treatment: Other: pancreatectomy

Detailed Description

The study design was a retrospective chart review and analysis of Traumatic Pancreas Transection(TPT) patients treated at National Cheng Kung University Hospital. The clinical records, including demographic data, computed tomographic location of pancreas transection with intraoperative confirmation of the pancreatic injury, associated intra-abdominal injuries, interval time between injury and operation, surgical procedure, presence of complication (pancreas and non pancreas related), timing of drain removal, duration of hospital stay and mortality recorded. The secondary end point of morbidity was assessed using the Clavien-Dindo classification.

Initial resuscitation was implemented using ATLS guide-lines. Damage-control laparotomy was applied in critically hemodynamic unstable patients.

In a relatively stable patient, damage control procedure using TAE to control solid organ ongoing hemorrhage and blood transfusion prior to pancreas and associated gastrointestinal surgery. Depending the surgeon preference, TPT patient underwent open or laparoscopic surgery, either using distal pancreatectomy, with or without splenectomy or pancreas preserving pancreatojejunostomy.

Early pancreas surgery is defined as undergoing pancreas reconstructive surgery within 48 hrs. while delayed is considered when beyond 48 hrs. Operative intervention in 42 each patient was individualized based on the surgeon's. Negative suction drain, using Jackson Pratt drain is placed just near proximal pancreas stump.

Drain was removed when the amount was less than 50 cc/day with or without drain amylase/lipase level is less than 3 times of normal serum level.

Morbidity was documented as systemic, intra-abdominal, or specific complications related directly to the pancreatic injury.

Mortality was defined as any cause of death during hospital days. All available postoperative data including blood glucose, Hb1AC, serum and drain amylase lipase level, timing of drain removal, morbidity, hospital stays and mortality was collected and analyzed.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Edgar D. Sy, MD; Phone Number: 3200 +886 2353535; Email: edsyfalcon2@yahoo.com.tw
• Study Contact Backup: Name: Chih-Jung Wang, MD; Phone Number: 3200 +886 2353535; Email: poemcage@gmail.com

Study Locations

• Taiwan
  • Tainan, Taiwan, 704
    • Recruiting
    • National Cheng Kung University Hospital
    • Contact: Chih-Jung Wang, MD; Phone Number: 3200 +886 2353535; Email: poemcage@gmail.com
    • Contact: Edgar D Sy, MD; Phone Number: 3200 +886 2353535; Email: edsyfalcon2@yahoo.com.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

hospital admission and underwent surgerical laparotomy in a single institution

Description

Inclusion Criteria:

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

Exclusion Criteria:

• negative pancreas injury by laparotomy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post opereative diabetes	occurence of diabetes following pancreas resection and pancreas preserving surgery	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post removal drain outcome	pseudocyst and abscess complication following drain removal	2 week to 4 weeks

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital
• Investigators: Study Chair: Yen- Shen Shan, National Cheng Kung University, College of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2008
• Primary Completion (Anticipated): January 1, 2030
• Study Completion (Anticipated): January 1, 2030

Study Registration Dates

• First Submitted: May 3, 2023
• First Submitted That Met QC Criteria: May 3, 2023
• First Posted (Actual): May 12, 2023

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: pancreas transection; A-ER-110-209 (Other Identifier: National Cheng Kung University Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: share data result finding in short term of incidence of post operative diabetes following distal pancreatectomy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No