Early on-demand drainage versus standard management in acute necrotizing pancreatitis with early persistent organ failure

The timing and indications for drainage in acute pancreatitis patients with acute necrotic collections and persistent organ failure: a pilot randomized controlled trial comparing early on-demand drainage and standard management

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16728921

Enrollment

Registered

2020-01-23

Start date

2018-07-02

Completion date

Unknown

Last updated

2022-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute pancreatitis Digestive System Acute pancreatitis

Interventions

Current interventions as of 16/06/2020: All study subjects were randomized to either early on-demand (EOD) PCD group or the standard management group on Day 7 (The day of onset of abdo

2. New-onset organ failure arising after study Day 7 or

3. Any worsening of any organ failure documented to be present on Day 7. After placement, PCDs were audited by the investigators on a daily basis and were removed when the daily drain

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Current participant inclusion criteria as of 16/06/2020: 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. Admitted within 7 days from onset of abdominal pain 3. Confirmed persistent organ failure (respiratory, circulatory, renal) failure (revised Marshall score = 2 points for at least 48 h) and still unresolved 7 days after onset 4. Age between 18 to 70 years old 5. Acute necrotic collection with available routes for ultrasound or CT guided percutaneous drainage Previous 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

Exclusion criteria

Exclusion criteria: Current participant exclusion criteria as of 16/06/2020: 1. Pregnancy 2. Chronic pancreatitis or pancreatic tumor-related pancreatitis 3. Percutaneous or transluminal drainage or surgery undertaken before admission 4. Previous history of cardio-pulmonary resuscitation during the present admission for AP 5. Expected to die within 48 h 6. Emergency surgery required due to active bleeding, bowel ischemia or necrosis, etc. 7. History of severe co-morbidities: 7.1. Greater than New York Heart Association class II heart failure 7.2. Active myocardial ischemia 7.3. History of cirrhosis 7.4 Chronic kidney disease with creatinine clearance <40 mL/min 7.5 Chronic obstructive pulmonary disease requiring home oxygen Previous 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

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 16/06/2020: Death and/or major complications within 90 days after randomization. Major complications refer to: new-onset organ failure that was not present 24h before randomization; bleeding requiring intervention; and gastrointestinal perforation or fistulas requiring intervention. THese will be assessed using medical records, the Revised Marshall Score, diagnosis based on CT, bacterial culture results, or the symptoms of the patients. Multiple events that happened in the same patient were considered as one incidence of major complications. Previous 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	—

Measure

Time frame

Current primary outcome measure as of 16/06/2020: Death and/or major complications within 90 days after randomization. Major complications refer to: new-onset organ failure that was not present 24h before randomization; bleeding requiring intervention; and gastrointestinal perforation or fistulas requiring intervention. THese will be assessed using medical records, the Revised Marshall Score, diagnosis based on CT, bacterial culture results, or the symptoms of the patients. Multiple events that happened in the same patient were considered as one incidence of major complications. Previous 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

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Secondary

Measure	Time frame
Current secondary outcome measures as of 16/06/2020: 1. Incidence of each of the individual components of death and the major complications listed in the primary outcome measure within 90 days after randomization 2. Incidence of infected pancreatic necrosis according to diagnosis based on CT, bacterial culture results, or the symptoms of the patient within 90 days after randomization 3. Incidence of sepsis according to SEPSIS 3.0 definition within 90 days after randomization 4. Incidence of external pancreatic fistula according to diagnosis based on CT, drainage, or the symptoms of the patient within 90 days after randomization 5. New receipt of organ support taken from the medical records at the time of discharge 6. The requirement for PCD, minimally invasive necrosectomy, open surgery, reoperation taken from the medical records at the time of discharge 7. Total number of PCD and minimally invasive necrosectomy procedures taken from the medical records at the time of discharge 8. The duration of organ failure and organ support between randomization and Day 28 (21 days in total) taken from the medical records at the time of discharge 9. Total expense taken from billing system at the time of discharge 10. Death by 180 days after randomization based on an additional follow-up Previous 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	—

Measure

Time frame

Current secondary outcome measures as of 16/06/2020: 1. Incidence of each of the individual components of death and the major complications listed in the primary outcome measure within 90 days after randomization 2. Incidence of infected pancreatic necrosis according to diagnosis based on CT, bacterial culture results, or the symptoms of the patient within 90 days after randomization 3. Incidence of sepsis according to SEPSIS 3.0 definition within 90 days after randomization 4. Incidence of external pancreatic fistula according to diagnosis based on CT, drainage, or the symptoms of the patient within 90 days after randomization 5. New receipt of organ support taken from the medical records at the time of discharge 6. The requirement for PCD, minimally invasive necrosectomy, open surgery, reoperation taken from the medical records at the time of discharge 7. Total number of PCD and minimally invasive necrosectomy procedures taken from the medical records at the time of discharge 8. The duration of organ failure and organ support between randomization and Day 28 (21 days in total) taken from the medical records at the time of discharge 9. Total expense taken from billing system at the time of discharge 10. Death by 180 days after randomization based on an additional follow-up Previous 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

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Countries

China

Contacts

Public ContactXiaowu Dong

dxw2333@163.com+86 (0)18512523817

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026