Acute PancreatitisNCT06023771
Invasive Intervention of Local Complications of Acute Pancreatitis
An observational study of Acute Pancreatitis, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Strategies for invasive intervention in acute pancreatitis include sequential or combined use of multiple drainage and debridement modalities. The more widely used is the step-up approach, which requires an individualized and multidisciplinary (internal medicine, interventional radiology, endoscopy, surgery, critical… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- Invasive intervention for acute pancreatitis
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Oct 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospitalized acute pancreatitis patients requiring invasive interventions.
Who may be able to join
- Admission diagnosis of acute pancreatitis;
- Localized complications confirmed by imaging examinations;
- Voluntary participation in the study and signing of an informed consent form.
Who cannot join
- Improved with conservative treatment without invasive interventions for local complications during hospitalization.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Dong Wu
About this study
Official title: Drainage and Debridement of Local Complications of Acute Pancreatitis: A Single-center Real-world Prospective Study
Strategies for invasive intervention in acute pancreatitis include sequential or combined use of multiple drainage and debridement modalities. The more widely used is the step-up approach, which requires an individualized and multidisciplinary (internal medicine, interventional radiology, endoscopy, surgery, critical care medicine, and nutritionists) approach. The available evidence from randomized controlled studies is from highly selected subject populations, and it is unclear whether the results can be applied to complex clinical situations in real clinics, and the optimal strategy for drainage of peripancreatic lesions in different patients still needs to be evaluated in the real world. This study intends to establish a prospective single-center cohort for real-world analysis to collect comprehensive clinic information and clinical outcomes, to evaluate the effectiveness and safety of existing intervention strategies, especially the timing and modality of interventions, in real-world clinical practice, and to explore the key factors affecting patient prognosis.
- Conditions
- Acute Pancreatitis
- Being tested
- Invasive intervention for acute pancreatitis
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive intervention for acute pancreatitisProcedure or surgery
Invasive interventions include drainage (endoscopic transmural drainage, imaging-guided percutaneous catheter drainage) and debridement (endoscopic debridement, videoscopic assisted retroperitoneal debridement, laparoscopic surgical debridement, open surgical debridement).
| Study group | Role | What they receive |
|---|---|---|
| Acute pancreatitis requiring invasive intervention | Single-center cohort of acute pancreatitis patients requiring invasive intervention for the treatment of local complications during the whole course of disease. Receives: Procedure: Invasive intervention for acute pancreatitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major complications or death
A composite of major complications (i.e., new-onset multiple organ failure or systemic complications, enterocutaneous fistula or perforation of a visceral organ requiring intervention, or intraabdominal bleeding requiring intervention) or death during admission or during the 6 months after discharge.
Measured: Day 1 from admission until 6 months after discharge
Secondary outcomes (11)
Organ failure
New-onset ( not present at any time in the 24 hours before first intervention) pulmonary failure, circulatory failure, or renal failure
Measured: Day 1 from admission until 6 months after discharge
Systemic complication
New-onset ( not present at any time in the 24 hours before first intervention) systematic complications such as disseminated intravascular coagulation, severe metabolic disturbance, and gastrointestinal bleeding
Measured: Day 1 from admission until 6 months after discharge
Enterocutaneous fistula
Secretion of fecal material from a percutaneous drain or drainage canal after removal of drains or from a surgical wound, either from small or large bowel; confirmed by imaging or during surgery
Measured: Day 1 from admission until 6 months after discharge
Perforation of visceral organ
Perforation requiring surgical, radiologic, or endoscopic intervention
Measured: Day 1 from admission until 6 months after discharge
Intraabdominal bleeding
Requiring surgical, radiologic, or endoscopic intervention
Measured: Day 1 from admission until 6 months after discharge
Pancreatic fistula
Output, through a percutaneous drain or drainage canal after removal of drains or from a surgical wound, of any measurable volume of fluid with an amylase content >3 times the serum amylase level
Measured: Day 1 from admission until 6 months after discharge
New-onset diabetes
Insulin or oral antidiabetic drugs required 6 mo after discharge; this requirement was not present before onset of pancreatitis
Measured: Day 1 from admission until 6 months after discharge
Use of pancreatic enzymes
Oral pancreatic-enzyme supplementation required to treat clinical symptoms of steatorrhea 6 mo after discharge; this requirement was not present before onset of pancreatitis
Measured: Day 1 from admission until 6 months after discharge
Length of hospitalization
Total days of hospitalization for the management of acute pancreatitis
Measured: Day 1 from admission until the 1 day of discharge
Length of intesive care
Total days in intesive care unit for the management of acute pancreatitis
Measured: Day 1 from admission until the 1 day of discharge
Total direct medical costs and indirect costs
Total direct medical costs and indirect costs during admission
Measured: Day 1 from admission until the 1 day of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study startOct 2023 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dong Wu, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023771
- Sponsor's protocol ID
- K4433
- Status last verified
- Aug 2023
- First submitted
- 17 Aug 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drainage and Debridement of Local Complications of Acute Pancreatitis: A Single-center Real-world Prospective Study
- ClinicalTrials.gov ID
- NCT06023771
- Acronym / sponsor ID
- K4433
- Conditions
- Acute Pancreatitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Strategies for invasive intervention in acute pancreatitis include sequential or combined use of multiple drainage and debridement modalities. The more widely used is the step-up approach, which requires an individualized and multidisciplinary (internal medicine, interventional radiology, endoscopy, surgery, critical care medicine, and nutritionists) approach. The available evidence from randomized controlled studies is from highly selected subject populations, and it is unclear whether the results can be applied to complex clinical situations in real clinics, and the optimal strategy for drainage of peripancreatic lesions in different patients still needs to be evaluated in the real world. This study intends to establish a prospective single-center cohort for real-world analysis to collect comprehensive clinic information and clinical outcomes, to evaluate the effectiveness and safety of existing intervention strategies, especially the timing and modality of interventions, in real-world clinical practice, and to explore the key factors affecting patient prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute pancreatitis requiring invasive intervention | – | Procedure: Invasive intervention for acute pancreatitisSingle-center cohort of acute pancreatitis patients requiring invasive intervention for the treatment of local complications during the whole course of disease. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospitalized acute pancreatitis patients requiring invasive interventions.
Key inclusion criteria (3 listed)
- Admission diagnosis of acute pancreatitis;
- Localized complications confirmed by imaging examinations;
- Voluntary participation in the study and signing of an informed consent form.
Key exclusion criteria (1 listed)
- Improved with conservative treatment without invasive interventions for local complications during hospitalization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invasive intervention for acute pancreatitisInvasive interventions include drainage (endoscopic transmural drainage, imaging-guided percutaneous catheter drainage) and debridement (endoscopic debridement, videoscopic assisted retroperitoneal debridement, laparoscopic surgical debridement, open surgical debridement). | Procedure or surgery | Acute pancreatitis requiring invasive intervention |
Primary outcome
Major complications or death
Time frame: Day 1 from admission until 6 months after discharge
A composite of major complications (i.e., new-onset multiple organ failure or systemic complications, enterocutaneous fistula or perforation of a visceral organ requiring intervention, or intraabdominal bleeding requiring intervention) or death during admission or during the 6 months after discharge.
11 secondary outcomes
Organ failure
Time frame: Day 1 from admission until 6 months after discharge
Systemic complication
Time frame: Day 1 from admission until 6 months after discharge
Enterocutaneous fistula
Time frame: Day 1 from admission until 6 months after discharge
Perforation of visceral organ
Time frame: Day 1 from admission until 6 months after discharge
Intraabdominal bleeding
Time frame: Day 1 from admission until 6 months after discharge
Pancreatic fistula
Time frame: Day 1 from admission until 6 months after discharge
New-onset diabetes
Time frame: Day 1 from admission until 6 months after discharge
Use of pancreatic enzymes
Time frame: Day 1 from admission until 6 months after discharge
Length of hospitalization
Time frame: Day 1 from admission until the 1 day of discharge
Length of intesive care
Time frame: Day 1 from admission until the 1 day of discharge
Total direct medical costs and indirect costs
Time frame: Day 1 from admission until the 1 day of discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dong Wu principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pancreatitis, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dong Wu (18612671010, wudong@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major complications or death (time frame: Day 1 from admission until 6 months after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.