Early Versus Standard Endoscopic Interventions for Peripancreatic Fluid Collections

NCT05281458 | Unknown

• 1 other identifier: 2021-114
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pancreatitis; Peripancreatic Fluid Collections; Endoscopic Ultrasound-Guided Drainage; Pancreatic Fluid Collections

Keywords

Acute Pancreatitis; Peripancreatic Fluid Collections; Endoscopic Ultrasound; Endoscopic Drainage

Outcome Measures

Primary Outcomes (2)

• 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.

  1-4 week

• Number of Participants with New-onset multi-organ failure after intervention

  1-4 week

Secondary Outcomes (4)

• Rates of mortality

  6 months

• Length of hospital stay

  3 months

• Length of ICU stays

  up to 3 months

• Related complications

  1 month

Study Arms (2)

Early endoscopic interventions for AP

EXPERIMENTAL

Participants in the intervention group will undergo EUS guided drainage earlier (≤1 weeks) in the disease course.

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.

Interventions

Early drainage of peripancreatic fluid collections PROCEDURE

Participants will undergo EUS guided drainage earlier (≤1 weeks) in the disease course.

Early endoscopic interventions for AP

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead
• Second Affiliated Hospital of Soochow University: collaborator
• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: collaborator
• Ruijin Hospital: collaborator

Study Sites (1)

Shanghai General Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

Related Publications (10)

• Hines OJ, Pandol SJ. Management of severe acute pancreatitis. BMJ. 2019 Dec 2;367:l6227. doi: 10.1136/bmj.l6227.

  PMID: 31791953 BACKGROUND

• 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.

  PMID: 21478061 BACKGROUND

• 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.

  PMID: 30146334 BACKGROUND

• 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.

  PMID: 28050922 BACKGROUND

• 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.

  PMID: 31479658 BACKGROUND

• 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.

  PMID: 30279466 BACKGROUND

• 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.

  PMID: 30568390 BACKGROUND

• 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.

  PMID: 33318376 BACKGROUND

• 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.

  PMID: 23100216 BACKGROUND

• Mederos MA, Reber HA, Girgis MD. Acute Pancreatitis: A Review. JAMA. 2021 Jan 26;325(4):382-390. doi: 10.1001/jama.2020.20317.

  PMID: 33496779 BACKGROUND

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Central Study Contacts

Baiwen Li

CONTACT

(+86)021-37798977; muzibowen@126.com

Kui Peng

CONTACT

(+86)021-37798977; drpeng@alumni.sjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Digestive Endoscopy Center

Study Record Dates

• First Submitted: February 19, 2022
• First Posted: March 16, 2022
• Study Start: September 15, 2021
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 8, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)