Management of Traumatic Pancreas Transection

Pancreatectomy Clinical Trial

Official title:

Surgical Management of Traumatic Pancreas Transection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05856474
• Other study ID #: pancreas transection
• Secondary ID: A-ER-110-209
• Status: Recruiting
• Start date: January 1, 2008
• Est. completion date: January 1, 2030

Study information

• Verified date: April 2023
• Source: National Cheng-Kung University Hospital
• Contact: Edgar D. Sy, MD
• Phone: +886 2353535
• Email: edsyfalcon2[@]yahoo.com.tw
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 1, 2030
• Est. primary completion date: January 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• negative pancreas injury by laparotomy

Related Conditions & MeSH terms

• Pancreatectomy

Intervention

Other:
• pancreatectomy
pancreaserving surgery, using end to side or end to end, pancreaticojejunostomy

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

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. — View 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: 10.4 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post opereative diabetes	occurence of diabetes following pancreas resection and pancreas preserving surgery	6 month
Secondary	post removal drain outcome	pseudocyst and abscess complication following drain removal	2 week to 4 weeks