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NCT Number: NCT05856474

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

Recruiting

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Key information

Conditions

Age range

1 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • negative pancreas injury by laparotomy

Treatment and study plan

Pancreatectomy

Other

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

Other names: pancreaticojejunostomy

Primary outcomes

  1. post opereative diabetes

    Time frame: 6 month

    occurence of diabetes following pancreas resection and pancreas preserving surgery

Secondary outcomes

  1. post removal drain outcome

    Time frame: 2 week to 4 weeks

    pseudocyst and abscess complication following drain removal

Study contacts

Contact information is provided by the study sponsor or research team.

Chih-Jung Wang, MD

CONTACT

[email protected]

+886 2353535 ext. 3200

Edgar D. Sy, MD

CONTACT

[email protected]

+886 2353535 ext. 3200

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

Surgical Management of Traumatic Pancreas Transection

Important dates

Study start
2008
Primary completion
2030
Study completion
2030
First posted
May 12, 2023
Registry last updated
May 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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