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

Necrotizing Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06380842
• Other study ID #: 2023HX1970
• Status: Not yet recruiting
• Start date: April 15, 2024
• Est. completion date: December 30, 2026

Study information

• Verified date: March 2024
• Source: West China Hospital
• Contact: Chunling Jiang, PhD
• Phone: 18980601096
• Email: jiangchunling[@]scu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 30, 2026
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Necrotizing Pancreatitis
• Pancreatitis
• Pancreatitis, Acute Necrotizing
• Sepsis

Intervention

Other:
• Necrotizing Pancreatitis patients' organ dysfunction progression
Study the dynamic nature of organ dysfunction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chunling Jiang

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure organ dysfunction change after open necrosectomy with respect to time	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	up to postoperative day 7, or at hospital discharge, whichever comes first
Secondary	incidence of a composite of major complications	Major complications were defined as new-onset organ failure (ie, cardiovascular, pulmonary, or renal)	up to postoperative day 28
Secondary	Incidence of ICU mortality	Death occurred in ICU	through study completion, an average of 1year
Secondary	Incidence of hospital mortality	Death occurred in hospital	through study completion, an average of 1 year
Secondary	Incidence of 28-day mortality	Death occurred within 28-day after surgery	through study completion, an average of 1 year
Secondary	Incidence of one year mortality	Death occurred within one year after surgery	through study completion, an average of 1 year
Secondary	ICU length of hospital stay	Determined by the number of days from ICU admittance to discharge from ICU	through study completion, an average of 1 year
Secondary	Length of hospital stay	Determined by the number of days from admittance to discharge	through study completion,an average of 1 year
Secondary	The pancreatic symptoms score	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.	up to 1 year
Secondary	The levels of inflammatory factor CRP	Peripheral blood CRP	preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first.
Secondary	The levels of inflammatory cytokines IL-6	cytokines IL-6	preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first.
Secondary	The levels of inflammatory procalcitonin	procalcitonin was measured at preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first.	preoperative, postoperative day 1, day 3 and day 7 or at hospital discharge, whichever came first.