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Organ Dysfunction Change in Acute Necrotizing Pancreatitis Patients With Sepsis After Open Necrosectomy

C

Chunling Jiang

Status

Enrolling

Conditions

Necrotizing Pancreatitis

Treatments

Other: Necrotizing Pancreatitis patients' organ dysfunction progression

Study type

Observational

Funder types

Other

Identifiers

NCT06380842
2023HX1970

Details and patient eligibility

About

The purpose of this study is to characterize organ dysfunction change in acute necrotizing pancreatitis patients with sepsis after open necrosectomy.

Full description

Before surgery, study participants will be asked questions about age, gender, education level, etc. Study participants will also be questioned regarding pancreatic symptoms, as measured on the patient-Reported Outcome Scale in Acute Pancreatitis (including, pain, abdominal distention, eating, bowel movements, nausea and vomiting, thirst, and weakness). Organ dysfunction was defined according to the sequential organ failure assessment (SOFA) score. The SOFA score will be measured at preoperative (T1), postoperative day 1 (T2), postoperative day 3 (T3), postoperative day 7, or at hospital discharge, whichever comes first (T4). Following discharge from the hospital, study participants will be contacted at 1 month, 3 months, 6 months, and 1 year after surgery, and asked to complete a survey about their pancreatic symptoms and survival status after surgery.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Patients 18 years or older
  2. Diagnosis of Acute pancreatitis according to the revised Atlanta classification, requires two of the following three criteria: (A) typical abdominal pain, (B) an increase in serum amylase or lipase levels higher than three times the upper limit of normality, and (C) signs of AP in imaging
  3. Patients with confirmed or suspected infected pancreatic or peripancreatic necrosis were scheduled for open necrosectomy
  4. Meet Sepsis-3 criteria

Exclusion criteria

  1. Patients refuse to participate
  2. Patients undergo repeat surgery on the same site

Trial design

200 participants in 1 patient group

Pancreatitis with sepsis patients' organ dysfunction progression after open necrosectomy
Description:
Acute necrotizing pancreatitis patients with sepsis undergoing open necrosectomy will be measured SOFA scores at a special time point to characterize organ dysfunction experience profiles.
Treatment:
Other: Necrotizing Pancreatitis patients' organ dysfunction progression

Trial contacts and locations

1

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Central trial contact

Qian Li, PhD; Chunling Jiang, PhD

Data sourced from clinicaltrials.gov

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