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NCT Number: NCT06380842

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

West China Hospital, Sichuan University

Chengdu, China, 610041

Location status: Recruiting

Location contact

Fengming Luo, PhD

CONTACT

[email protected]

02885423593

About this study

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). Participants who provide optional consent for biospecimen collection will have peripheral venous blood samples (5-10 mL) collected at predefined preoperative and postoperative time points. Samples will be processed and stored for biomarker analyses, including inflammatory marker measurement, metabolomic profiling, and other exploratory analyses related to the objectives of this study. 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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients 18 years or older
  • 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
  • Patients with confirmed or suspected infected pancreatic or peripancreatic necrosis were scheduled for open necrosectomy
  • Meet Sepsis-3 criteria

Exclusion criteria

  • Patients refuse to participate
  • Patients undergo repeat surgery on the same site

Treatment and study plan

Necrotizing Pancreatitis patients' organ dysfunction progression

Other

Study the dynamic nature of organ dysfunction

Primary outcomes

  1. Measure organ dysfunction change after open necrosectomy with respect to time

    Time frame: up to postoperative day 7, or at hospital discharge, whichever comes first

    Organ dysfunction will be measured using sequential organ failure assessment score scale. The scores range from 0 (normal) to 4(most abnormal) for each organ, with higher scores indicating worse health status

Secondary outcomes

  1. incidence of a composite of major complications

    Time frame: up to postoperative day 28

    Major complications were defined as new-onset organ failure (ie, cardiovascular, pulmonary, or renal)

  2. Incidence of ICU mortality

    Time frame: through study completion, an average of 1year

    Death occurred in ICU

  3. Incidence of hospital mortality

    Time frame: through study completion, an average of 1 year

    Death occurred in hospital

  4. Incidence of 28-day mortality

    Time frame: through study completion, an average of 1 year

    Death occurred within 28-day after surgery

  5. Incidence of one year mortality

    Time frame: through study completion, an average of 1 year

    Death occurred within one year after surgery

  6. ICU length of hospital stay

    Time frame: through study completion, an average of 1 year

    Determined by the number of days from ICU admittance to discharge from ICU

  7. Length of hospital stay

    Time frame: through study completion,an average of 1 year

    Determined by the number of days from admittance to discharge

  8. The pancreatic symptoms score

    Time frame: up to 1 year

    Pancreatic symptom scores will be measured at preoperative, postoperative day 1, day 2, day 3, day 7, or at hospital discharge, whichever comes first, at 1 month, 3 months, 6 months, and 1 year postoperatively. Both were measured using the Patient-Reported Outcome Scale, which ranges from 0 to 10 for each symptom; The overall range is from 0 to 70, with higher scores indicating higher symptom intensity.

  9. The levels of inflammatory factor CRP

    Time frame: preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first.

    Peripheral blood CRP

  10. The levels of inflammatory cytokines IL-6

    Time frame: preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first.

    cytokines IL-6

  11. The levels of inflammatory procalcitonin

    Time frame: preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first.

    procalcitonin was measured at preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first.

Study contacts

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

Chunling Jiang, PhD

CONTACT

[email protected]

18980601096

Qian Li, PhD

CONTACT

[email protected]

18980601096

Sponsors and collaborators

Lead sponsor

Chunling Jiang

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2024
Registry last updated
Jul 10, 2026

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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