Management of Traumatic Pancreas Transection

NCT ID: NCT05856474

Last Updated: 2023-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-01

Study Completion Date

2030-01-01

Brief Summary

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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

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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.

Conditions

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Pancreatectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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pancreatectomy

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

Intervention Type OTHER

Other Intervention Names

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pancreaticojejunostomy

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* negative pancreas injury by laparotomy
Minimum Eligible Age

1 Year

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yen- Shen Shan

Role: STUDY_CHAIR

National Cheng Kung University, College of Medicine

Locations

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National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Edgar D. Sy, MD

Role: CONTACT

+886 2353535 ext. 3200

Chih-Jung Wang, MD

Role: CONTACT

+886 2353535 ext. 3200

Facility Contacts

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Edgar D Sy, MD

Role: primary

+886 2353535 ext. 3200

Chih-Jung Wang, MD

Role: backup

+886 2353535 ext. 3200

References

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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.

Reference Type RESULT
PMID: 17879305 (View on PubMed)

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.

Reference Type RESULT
PMID: 28396721 (View on PubMed)

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.

Reference Type RESULT
PMID: 26038044 (View on PubMed)

Other Identifiers

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A-ER-110-209

Identifier Type: OTHER

Identifier Source: secondary_id

pancreas transection

Identifier Type: -

Identifier Source: org_study_id

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