Acute PancreatitisNCT05281458
Early Versus Standard Endoscopic Interventions for Peripancreatic Fluid Collections
A study testing Early drainage of peripancreatic fluid collections in people with Acute Pancreatitis and Peripancreatic Fluid Collections, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Acute pancreatitis is a complex gastrointestinal disease with a variable course that is often difficult to predict early in its development. The majority of cases are mild, self-limited, and follow an uncomplicated course. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Pancreatitis, Peripancreatic Fluid Collections, Endoscopic Ultrasound-Guided Drainage
- What is being tested?
- Early drainage of peripancreatic fluid collections
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2021to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with PFC;
- All patients with PFC will be screened for eligibility including a protocolized approach;
- Patients admitted within 72 hours of onset
Who cannot join
- More than 30 days after onset of acute pancreatitis
- Pregnant women
- Documented chronic pancreatitis
- Inability to gave informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai General Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200080
Xiaodong Sun, (+86)021-63240090, sfph_edu2@163.com
About this study
Official title: Postponed or Early Drainage of Peripancreatic Fluid Collections: a Randomized Controlled Multicenter Study
Acute pancreatitis is a complex gastrointestinal disease with a variable course that is often difficult to predict early in its development. The majority of cases are mild, self-limited, and follow an uncomplicated course. However, 10-20% of cases can be associated with pancreatic or peripancreatic fluid collections, or both. Infected necrosis complicates 10% of all acute pancreatitis episodes and is associated with a mortality of 15-20%. Current guidelines for necrotizing pancreatitis recommend to postpone drainage until 4 or more weeks after initial presentation to allow collections to "walled-off". However, evidence of infection with clinical deterioration despite maximum support may mandate earlier intervention. It is unclear whether such delay is needed for drainage or whether earlier endoscopic intervention could actually be beneficial in the current approach. The aims of this randomized, controlled, multicenter study is to evaluate whether early endoscopic drainage in patients with peripancreatic fluid collection is superior to postponed intervention in the current practice.
Read the detailed description
EUS guided drainage is now the preferred route for peripancreatic fluid collections (PFC). It belongs to transmural drainage and is accomplished by creating a fistula and placing a stent between the gastric or duodenal lumen and the PFC. The size of the PFC and percentage of solid debris were noted prior to puncture, and the optimal site of transluminal puncture was identified using EUS. Participants will be randomly allocated to either the intervention or the control group. Participants in the intervention group will undergo EUS guided drainage earlier (≤1 weeks) in the disease course. The follow-up duration is 6 months from randomization. All patients undergo imaging (contrast enhanced computed tomography) at 3- and 6-months post randomization.
- Conditions
- Acute Pancreatitis, Peripancreatic Fluid Collections, Endoscopic Ultrasound-Guided Drainage, Pancreatic Fluid Collections
- Being tested
- Early drainage of peripancreatic fluid collections
- Keywords
- Acute Pancreatitis, Peripancreatic Fluid Collections, Endoscopic Ultrasound, Endoscopic Drainage
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early drainage of peripancreatic fluid collectionsProcedure or surgery
Participants will undergo EUS guided drainage earlier (≤1 weeks) in the disease course.
| Study group | Role | What they receive |
|---|---|---|
| Early endoscopic interventions for AP | Experimental | Participants in the intervention group will undergo EUS guided drainage earlier (≤1 weeks) in the disease course. Receives: Procedure: Early drainage of peripancreatic fluid collections |
| Standard endoscopic interventions for AP | No intervention | Participants in the control group will have postponed drainage, preferably until AP progress to the walled-off necrosis stage. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Bedside Index of Severe Acute Pancreatitis (BISAP)
Comparison of BISAP changes between the two groups after different treatments. Also compare the number of participants with BISAP ≥3. BISAP was designed as a predictor of mortality based on 5 variables: blood urea nitrogen (BUN) level greater than 25 mg/dL, impaired mental status, systemic inflammatory response syndrome (SIRS), age older than 60 years, or radiographic evidence of pleural effusion within the first 24 hours of admission. A BISAP score of 3 or greater was associated with developing organ failure, and a higher scores mean a worse outcome.
Measured: 1-4 week
Number of Participants with New-onset multi-organ failure after intervention
Measured: 1-4 week
Secondary outcomes (4)
Rates of mortality
Measured: 6 months
Length of hospital stay
Measured: 3 months
Length of ICU stays
Measured: up to 3 months
Related complications
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start15 Sep 2021
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital of Soochow University, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Ruijin Hospital
- Responsible party
- Principal investigator, Baiwen Li, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281458
- Sponsor's protocol ID
- 2021-114
- Status last verified
- Jun 2023
- First submitted
- 19 Feb 2022
- Last updated
- 8 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hines OJ, Pandol SJ. Management of severe acute pancreatitis. BMJ. 2019 Dec 2;367:l6227. doi: 10.1136/bmj.l6227.
PubMed 31791953Zerem E, Imamovic G, Susic A, Haracic B. Step-up approach to infected necrotising pancreatitis: a 20-year experience of percutaneous drainage in a single centre. Dig Liver Dis. 2011 Jun;43(6):478-83. doi: 10.1016/j.dld.2011.02.020. Epub 2011 Apr 8.
PubMed 21478061Mallick B, Dhaka N, Gupta P, Gulati A, Malik S, Sinha SK, Yadav TD, Gupta V, Kochhar R. An audit of percutaneous drainage for acute necrotic collections and walled off necrosis in patients with acute pancreatitis. Pancreatology. 2018 Oct;18(7):727-733. doi: 10.1016/j.pan.2018.08.010. Epub 2018 Aug 21.
PubMed 30146334Hongyin L, Zhu H, Tao W, Ning L, Weihui L, Jianfeng C, Hongtao Y, Lijun T. Abdominal paracentesis drainage improves tolerance of enteral nutrition in acute pancreatitis: a randomized controlled trial. Scand J Gastroenterol. 2017 Apr;52(4):389-395. doi: 10.1080/00365521.2016.1276617. Epub 2017 Jan 4.
PubMed 28050922Baron TH, DiMaio CJ, Wang AY, Morgan KA. American Gastroenterological Association Clinical Practice Update: Management of Pancreatic Necrosis. Gastroenterology. 2020 Jan;158(1):67-75.e1. doi: 10.1053/j.gastro.2019.07.064. Epub 2019 Aug 31.
PubMed 31479658Trikudanathan G, Tawfik P, Amateau SK, Munigala S, Arain M, Attam R, Beilman G, Flanagan S, Freeman ML, Mallery S. Early (<4 Weeks) Versus Standard (>/= 4 Weeks) Endoscopically Centered Step-Up Interventions for Necrotizing Pancreatitis. Am J Gastroenterol. 2018 Oct;113(10):1550-1558. doi: 10.1038/s41395-018-0232-3. Epub 2018 Oct 2.
PubMed 30279466Liu RH, Wen Y, Sun HY, Liu CY, Zhang YF, Yang Y, Huang QL, Tang JJ, Huang CC, Tang LJ. Abdominal paracentesis drainage ameliorates severe acute pancreatitis in rats by regulating the polarization of peritoneal macrophages. World J Gastroenterol. 2018 Dec 7;24(45):5131-5143. doi: 10.3748/wjg.v24.i45.5131.
PubMed 30568390Rana SS, Verma S, Kang M, Gorsi U, Sharma R, Gupta R. Comparison of endoscopic versus percutaneous drainage of symptomatic pancreatic necrosis in the early (< 4 weeks) phase of illness. Endosc Ultrasound. 2020 Nov-Dec;9(6):402-409. doi: 10.4103/eus.eus_65_20.
PubMed 33318376Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
PubMed 23100216Mederos MA, Reber HA, Girgis MD. Acute Pancreatitis: A Review. JAMA. 2021 Jan 26;325(4):382-390. doi: 10.1001/jama.2020.20317.
PubMed 33496779
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postponed or Early Drainage of Peripancreatic Fluid Collections: a Randomized Controlled Multicenter Study
- ClinicalTrials.gov ID
- NCT05281458
- Acronym / sponsor ID
- 2021-114
- Conditions
- Acute Pancreatitis, Peripancreatic Fluid Collections, Endoscopic Ultrasound-Guided Drainage, Pancreatic Fluid Collections
- Keywords
- Acute Pancreatitis, Peripancreatic Fluid Collections, Endoscopic Ultrasound, Endoscopic Drainage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Soochow University, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Ruijin Hospital
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 16 Mar 2022 (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.
Acute pancreatitis is a complex gastrointestinal disease with a variable course that is often difficult to predict early in its development. The majority of cases are mild, self-limited, and follow an uncomplicated course. However, 10-20% of cases can be associated with pancreatic or peripancreatic fluid collections, or both. Infected necrosis complicates 10% of all acute pancreatitis episodes and is associated with a mortality of 15-20%. Current guidelines for necrotizing pancreatitis recommend to postpone drainage until 4 or more weeks after initial presentation to allow collections to "walled-off". However, evidence of infection with clinical deterioration despite maximum support may mandate earlier intervention. It is unclear whether such delay is needed for drainage or whether earlier endoscopic intervention could actually be beneficial in the current approach. The aims of this randomized, controlled, multicenter study is to evaluate whether early endoscopic drainage in patients with peripancreatic fluid collection is superior to postponed intervention in the current practice.
Detailed description
EUS guided drainage is now the preferred route for peripancreatic fluid collections (PFC). It belongs to transmural drainage and is accomplished by creating a fistula and placing a stent between the gastric or duodenal lumen and the PFC. The size of the PFC and percentage of solid debris were noted prior to puncture, and the optimal site of transluminal puncture was identified using EUS. Participants will be randomly allocated to either the intervention or the control group. Participants in the intervention group will undergo EUS guided drainage earlier (≤1 weeks) in the disease course. The follow-up duration is 6 months from randomization. All patients undergo imaging (contrast enhanced computed tomography) at 3- and 6-months post randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early endoscopic interventions for AP | Experimental | Procedure: Early drainage of peripancreatic fluid collectionsParticipants in the intervention group will undergo EUS guided drainage earlier (≤1 weeks) in the disease course. |
| Standard endoscopic interventions for AP | No intervention | –Participants in the control group will have postponed drainage, preferably until AP progress to the walled-off necrosis stage. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients with PFC;
- All patients with PFC will be screened for eligibility including a protocolized approach;
- Patients admitted within 72 hours of onset
Key exclusion criteria (4 listed)
- More than 30 days after onset of acute pancreatitis
- Pregnant women
- Documented chronic pancreatitis
- Inability to gave informed consent
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 |
|---|---|---|
| Early drainage of peripancreatic fluid collectionsParticipants will undergo EUS guided drainage earlier (≤1 weeks) in the disease course. | Procedure or surgery | Early endoscopic interventions for AP |
Primary outcome
Changes in the Bedside Index of Severe Acute Pancreatitis (BISAP)
Time frame: 1-4 week
Comparison of BISAP changes between the two groups after different treatments. Also compare the number of participants with BISAP ≥3. BISAP was designed as a predictor of mortality based on 5 variables: blood urea nitrogen (BUN) level greater than 25 mg/dL, impaired mental status, systemic inflammatory response syndrome (SIRS), age older than 60 years, or radiographic evidence of pleural effusion within the first 24 hours of admission. A BISAP score of 3 or greater was associated with developing organ failure, and a higher scores mean a worse outcome.
Number of Participants with New-onset multi-organ failure after intervention
Time frame: 1-4 week
4 secondary outcomes
Rates of mortality
Time frame: 6 months
Length of hospital stay
Time frame: 3 months
Length of ICU stays
Time frame: up to 3 months
Related complications
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Background: PubMed 31791953Hines OJ, Pandol SJ. Management of severe acute pancreatitis. BMJ. 2019 Dec 2;367:l6227. doi: 10.1136/bmj.l6227.
- Background: PubMed 21478061Zerem E, Imamovic G, Susic A, Haracic B. Step-up approach to infected necrotising pancreatitis: a 20-year experience of percutaneous drainage in a single centre. Dig Liver Dis. 2011 Jun;43(6):478-83. doi: 10.1016/j.dld.2011.02.020. Epub 2011 Apr 8.
- Background: PubMed 30146334Mallick B, Dhaka N, Gupta P, Gulati A, Malik S, Sinha SK, Yadav TD, Gupta V, Kochhar R. An audit of percutaneous drainage for acute necrotic collections and walled off necrosis in patients with acute pancreatitis. Pancreatology. 2018 Oct;18(7):727-733. doi: 10.1016/j.pan.2018.08.010. Epub 2018 Aug 21.
- Background: PubMed 28050922Hongyin L, Zhu H, Tao W, Ning L, Weihui L, Jianfeng C, Hongtao Y, Lijun T. Abdominal paracentesis drainage improves tolerance of enteral nutrition in acute pancreatitis: a randomized controlled trial. Scand J Gastroenterol. 2017 Apr;52(4):389-395. doi: 10.1080/00365521.2016.1276617. Epub 2017 Jan 4.
- Background: PubMed 31479658Baron TH, DiMaio CJ, Wang AY, Morgan KA. American Gastroenterological Association Clinical Practice Update: Management of Pancreatic Necrosis. Gastroenterology. 2020 Jan;158(1):67-75.e1. doi: 10.1053/j.gastro.2019.07.064. Epub 2019 Aug 31.
- Background: PubMed 30279466Trikudanathan G, Tawfik P, Amateau SK, Munigala S, Arain M, Attam R, Beilman G, Flanagan S, Freeman ML, Mallery S. Early (<4 Weeks) Versus Standard (>/= 4 Weeks) Endoscopically Centered Step-Up Interventions for Necrotizing Pancreatitis. Am J Gastroenterol. 2018 Oct;113(10):1550-1558. doi: 10.1038/s41395-018-0232-3. Epub 2018 Oct 2.
- Background: PubMed 30568390Liu RH, Wen Y, Sun HY, Liu CY, Zhang YF, Yang Y, Huang QL, Tang JJ, Huang CC, Tang LJ. Abdominal paracentesis drainage ameliorates severe acute pancreatitis in rats by regulating the polarization of peritoneal macrophages. World J Gastroenterol. 2018 Dec 7;24(45):5131-5143. doi: 10.3748/wjg.v24.i45.5131.
- Background: PubMed 33318376Rana SS, Verma S, Kang M, Gorsi U, Sharma R, Gupta R. Comparison of endoscopic versus percutaneous drainage of symptomatic pancreatic necrosis in the early (< 4 weeks) phase of illness. Endosc Ultrasound. 2020 Nov-Dec;9(6):402-409. doi: 10.4103/eus.eus_65_20.
- Background: PubMed 23100216Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
- Background: PubMed 33496779Mederos MA, Reber HA, Girgis MD. Acute Pancreatitis: A Review. JAMA. 2021 Jan 26;325(4):382-390. doi: 10.1001/jama.2020.20317.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early drainage of peripancreatic fluid collections in people with Acute Pancreatitis and Peripancreatic Fluid Collections, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine 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 4 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: status not confirmed, as of the sponsor's last update on 8 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Baiwen Li ((+86)021-37798977, muzibowen@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Bedside Index of Severe Acute Pancreatitis (BISAP) (time frame: 1-4 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05281458, which also lists 10 linked publications.
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 8 Jun 2023.