Early on-demand drainage versus standard management among acute necrotizing pancreatitis patients complicated by persistent organ failure

Not Applicable

• Conditions: Acute pancreatitis; Digestive System

• Registration Number: ISRCTN91106416
• Lead Sponsor: Department of science and technology of Jiangsu province

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-21
• Last Update Posted: 29 June 2020
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Current inclusion criteria as of 18/06/2020:
1. Aged 18 to 70 years
2. Able to provide informed consent
3. Confirmed diagnosis of AP
4. CT diagnosis of acute necrotic collection (ANC)
5. Technically able to be drained percutaneously, by ultrasound or CT guidance
6. Confirmed persistent organ failure (either respiratory, renal and/or cardiovascular lasting for more than 48 hours) that had not resolved by Day 7
7. During Day 8-Day 21, one or more of these criteria:
7.1. New-onset organ failure not present on Day 7 (no alleviation within 24 hours)
7.2. Organ failure (either single or multiple, modified Marshall score or SOFA score=2) persist
for seven natural days from Day 1
7.3. Aggravation of organ failure from that on Day 7 evidenced by increased modified Marshall
score or SOFA score (no alleviation within 24 hours)

Previous inclusion criteria:
Inclusion criteria for the screening period
Screening period starts from day 8 and extends to the end of the third week (day 21) consisting of 14 days:
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. Necrotic collection with available routes for ultrasound or CT guided percutaneous no matter sterile or infected
3. Confirmed persistent organ failure (either respiratory, renal or cardiovascular lasting for more than 48 hours), the organ failure score at day7 will be set as the baseline for the screening period
4. Age between 18 to 70 years old

Inclusion Criteria for randomization during screening period:
1. Patients in the screening period
2. Signs of deterioration from the baseline during the screening period including:
2.1. New-onset organ failure (no alleviation within 24 hours)
2.2. Unalleviated organ failure (either single or multiple, modified Marshall score=2) lasting for at least seven days including the duration before the screening period
2.3. Aggravation of organ failure from the baseline (either single or multiple) evidence by increased modified Marshall score (no alleviation within 24 hours)

Exclusion Criteria

Current exclusion criteria as of 18/06/2020:
1. Pregnant pancreatitis
2. Chronic pancreatitis
3. Pancreatic tumor-related pancreatitis
4. Percutaneous or transluminal drainage or surgery is undertaken before admission
5. Patients had a history of cardio-pulmonary resuscitation during this episode
6. Patients with a known history of severe cardiovascular, respiratory, renal or hepatic disease defined as (1) greater than New York Heart Association class II heart failure, (2) active myocardial ischemia or (3) cardiovascular intervention within previous 60 days, (4) history of cirrhosis or (5) chronic kidney disease with creatinine clearance< 40 mL/min, or (6) chronic obstructive pulmonary disease with requirement for home oxygen

Previous 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measure as of 18/06/2020:<br> Death and/ or major complications during the index admission from randomization to hospital discharge or death. Major complications refer to new-onset organ failure (cardiovascular, renal and respiratory), bleeding requiring intervention and gastrointestinal perforation or fistula<br> requiring intervention.<br><br> Previous primary outcome measure:<br> 1. All-cause mortality in hospital<br> 2. Major complications during the observational period<br>