Plain English Summary
Background and study aims
Acute necrotic collection (ANC) is one of the complications of acute pancreatitis. In patients with persistent organ failure (POF), namely, the most severe type of AP patients, ANC is very common and it is controversial that if early invasive intervention before confirming infection is beneficial in this entity. Based on the previous studies, most ANC could be well absorbed or demarcated naturally, and percutaneous drainage may lead to bacterial colonization or infection of pancreatic necrosis. So it was suggested to delay intervention in asymptomatic patients. However, considering the pathophysiology of SAP, despite the sterile nature, ANC always contains numerous enzymes and inflammatory mediators, which play important roles in the development of POF and SIRS. It is controversial whether a delayed strategy in patients showing clinical deterioration before clear signs or evidence of infection is beneficial or could even worsen the outcomes. The aim of this study is to compare the effect of organ function-directed and infection-directed intervention in patients with ANC combined with POF (more than a week).
Who can participate?
All adult patients admitted with a primary diagnosis of acute pancreatitis and persistent organ failure to the participating hospital of the Chinese Acute Pancreatitis Clinical Trials Group will be assessed for eligibility on a daily basis during their hospital stay.
What does the study involve?
Patients are randomly allocated to receive either organ function-directed or infection-directed intervention.
What are the possible benefits and risks of participating?
Participants may get some clinical benefit from the trial and some advice from doctors.
Where is the study run from?
Jinling Hospital affiliated to Nanjing University (China)
Who is funding the study?
Jiangsu Province Key Research and Development Program (Social Development) Project (China)
Who is the main contact?
1. Dr Dong Xiaowu
dxw2333@163.com
2. Dr Tong Zhihui
njzyantol@hotmail.com
Trial website
Contact information
Type
Public
Primary contact
Mr Xiaowu Dong
ORCID ID
https://orcid.org/0000-0002-5717-5384
Contact details
305 Zhongshan Road East
Nanjing
210000
China
+86 (0)18512523817
dxw2333@163.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
2018NZKY-009-01
Study information
Scientific title
Infection-directed versus organ-function-directed intervention in acute necrotizing pancreatitis complicated with persistent organ failure: a pilot study
Acronym
Study hypothesis
Current study hypothesis as of 31/01/2020:
For severe acute pancreatitis patients complicated with acute necrotic collection and persistent organ failure in the early stages of disease, organ function-directed interventions may improve patient organ function and prognosis. This pilot study aimed to compare the effect of organ function-directed and infection-directed intervention.
Previous study hypothesis:
For severe acute pancreatitis patients complicated with acute necrotic collection and persistent organ failure in the early stages of disease, organ function-directed interventions may improve patient organ function and prognosis. This randomized, controlled, multi-center study aimed to compare the effect of organ function-directed and infection-directed intervention.
Ethics approval
Approved 16/04/2018, Clinical trial ethics committee of the General Hospital of the Eastern Theater (305 Zhongshan Road East, Nanjing, Jiangsu, China; +861 (0)25-80863234; wuqiong80863234@163.com), ref: 2018NZKY-009-01
Study design
Randomized controlled open-label pilot trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a participant information sheet
Condition
Acute pancreatitis
Intervention
Current interventions as of 31/01/2020:
Randomization will occur in a 1:1 fashion with computer-generated random numbers.
Organ function-directed group:
In addition to the standard treatment, ultrasound or CT guided percutaneous drainage would be applied once meeting one of the following conditions:
1. New-onset organ failure (no alleviation within 24 hours)
2. Unalleviated organ failure (either single or multiple, modified Marshall score ≥2) lasting for at least 7 days after randomization
3. Aggravation of organ failure from the baseline (either single or multiple) evidenced by increased modified Marshall score (no alleviation within 24 hours)
Infection-directed group:
Intervention including catheter drainage and necrosectomy would be delayed until suspicion or diagnosis of pancreatic infection and preferably after encapsulation of the necrotic collection (after 4 weeks mostly).
Previous interventions:
Randomization will occur in a 1:1 fashion for each center (sample size of each center was predefined based on its volume) with computer-generated random numbers.
Organ function-directed group:
In addition to the standard treatment, ultrasound or CT guided percutaneous drainage would be applied once meeting one of the following conditions:
1. New-onset organ failure (no alleviation within 24 hours)
2. Unalleviated organ failure (either single or multiple, modified Marshall score ≥2) lasting for at least 7 days after randomization
3. Aggravation of organ failure from the baseline (either single or multiple) evidenced by increased modified Marshall score (no alleviation within 24 hours)
Infection-directed group:
Intervention including catheter drainage and necrosectomy would be delayed until suspicion or diagnosis of pancreatic infection and preferably after encapsulation of the necrotic collection (after 4 weeks mostly).
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
1. All-cause mortality in hospital according to the medical records at the time of discharge
2. Major complications, including organ failure measured using Revised Marshall Score at baseline and daily during observation, complications such as infected pancreatic necrosis, sepsis, abdominal bleeding and fistulas according to diagnosis based on CT, bacterial culture results or the symptoms of the patients
Secondary outcome measures
1. Incidence and timing of infected pancreatic necrosis according to diagnosis based on CT, bacterial culture results or the symptoms of the patients
2. Incidence and timing of sepsis according to diagnosis based on CT, bacterial culture results or the symptoms of the patients
3. Incidence and timing of other common complications such as abdominal bleeding and fistulas according to diagnosis based on CT or the symptoms of the patients
4. Requirement of open surgery taken from the medical records at the time of discharge
5. ICU duration taken from the medical records at the time of discharge
6. Hospital duration taken from the medical records at the time of discharge
7. Total cost taken from billing system at the time of discharge
Overall trial start date
01/06/2016
Overall trial end date
01/05/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Symptoms and signs of acute pancreatitis based on abdominal pain suggestive of AP, serum amylase at least three times the upper limit of normal, and/or characteristic findings of AP on computed tomography
2. The duration of disease up to 1 week (starting with abdominal pain)
3. Confirmed persistent organ failure (respiratory, circulatory, renal) failure (revised Marshall score ≥ 2 points and the duration of up to 48 hours)
4. Age between 18 to 70 years old
5. Necrotic collection with available routes for ultrasound or CT guided percutaneous no matter sterile or infected
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Total final enrolment
30
Participant exclusion criteria
1. Pregnant
2. Chronic pancreatitis, recurrent acute pancreatitis or pancreatic tumor-related pancreatitis
3. Percutaneous or transluminal drainage or surgery undertaken before admission
4. Previous history of cardio-pulmonary resuscitation
5. History of severe cardiovascular, respiratory, renal, hepatic, hematologic, or immunologic disease defined as:
5.1. Greater than New York Heart Association class II heart failure
5.2. Active myocardial ischemia
5.3. Cardiovascular intervention within the previous 60 days
5.4. History of cirrhosis
5.5 Chronic kidney disease with creatinine clearance< 40 mL/min
5.6 Chronic obstructive pulmonary disease with requirement for home oxygen
Recruitment start date
02/07/2018
Recruitment end date
12/08/2019
Locations
Countries of recruitment
China
Trial participating centre
Jinling Hospital affiliated to Nanjing University
305 Zhongshan Road East
Nanjing
210000
China
Sponsor information
Organisation
Jinling Hospital affiliated to Nanjing University
Sponsor details
305 Zhongshan Road East
Nanjing
210000
China
+86 (0)13851948781
njzyantol@hotmail.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Jiangsu Province Key Research and Development Program (Social Development) Project (BE2016749)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
31/12/2020
Participant level data
Other
Basic results (scientific)
Publication list