Clinical trial NCT05281458: Early Versus Standard Endoscopic Interventions for Peripancreatic Fluid Collections
Official title: Postponed or Early Drainage of Peripancreatic Fluid Collections: a Randomized Controlled Multicenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Pancreatitis
Peripancreatic Fluid Collections
Endoscopic Ultrasound-Guided Drainage
Pancreatic Fluid Collections
Keywords: Acute Pancreatitis
Peripancreatic Fluid Collections
Endoscopic Ultrasound
Endoscopic Drainage
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital of Soochow University
name: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
name: Ruijin Hospital
First posted: 2022-03-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Adult patients with PFC;
* All patients with PFC will be screened for eligibility including a protocolized approach;
* Patients admitted within 72 hours of onset

Exclusion Criteria:

* More than 30 days after onset of acute pancreatitis
* Pregnant women
* Documented chronic pancreatitis
* Inability to gave informed consent

Primary outcomes:
measure: Changes in the Bedside Index of Severe Acute Pancreatitis (BISAP)
timeFrame: 1-4 week
measure: Number of Participants with New-onset multi-organ failure after intervention
timeFrame: 1-4 week
Secondary outcomes:
measure: Rates of mortality
timeFrame: 6 months
measure: Length of hospital stay
timeFrame: 3 months
measure: Length of ICU stays
timeFrame: up to 3 months
measure: Related complications
timeFrame: 1 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
References:
citation: Hines OJ, Pandol SJ. Management of severe acute pancreatitis. BMJ. 2019 Dec 2;367:l6227. doi: 10.1136/bmj.l6227.
citation: Zerem 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.
citation: Mallick 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.
citation: Hongyin 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.
citation: Baron 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.
citation: Trikudanathan 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.
citation: Liu 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.
citation: Rana 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.
citation: Banks 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.
citation: Mederos MA, Reber HA, Girgis MD. Acute Pancreatitis: A Review. JAMA. 2021 Jan 26;325(4):382-390. doi: 10.1001/jama.2020.20317.