Clinical trial NCT05856474: Management of Traumatic Pancreas Transection
Official title: Surgical Management of Traumatic Pancreas Transection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatectomy
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospital admission and underwent surgerical laparotomy in a single institution

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

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* negative pancreas injury by laparotomy

Primary outcomes:
measure: post opereative diabetes
timeFrame: 6 month
Secondary outcomes:
measure: post removal drain outcome
timeFrame: 2 week to 4 weeks
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: National Cheng Kung University, College of Medicine
name: Yen- Shen Shan
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.