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Early Versus Standard Endoscopic Interventions for Peripancreatic Fluid Collections

Primary Purpose

Acute Pancreatitis, Peripancreatic Fluid Collections, Endoscopic Ultrasound-Guided Drainage

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Early drainage of peripancreatic fluid collections
Sponsored by
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pancreatitis focused on measuring Acute Pancreatitis, Peripancreatic Fluid Collections, Endoscopic Ultrasound, Endoscopic Drainage

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai General Hospital, Shanghai Jiaotong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Early endoscopic interventions for AP

Standard endoscopic interventions for AP

Arm Description

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

Participants in the control group will have postponed drainage, preferably until AP progress to the walled-off necrosis stage.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rates of mortality
Length of hospital stay
Length of ICU stays
Related complications

Full Information

First Posted
February 19, 2022
Last Updated
June 7, 2023
Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
Second Affiliated Hospital of Soochow University, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Ruijin Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05281458
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
Second Affiliated Hospital of Soochow University, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis, Peripancreatic Fluid Collections, Endoscopic Ultrasound-Guided Drainage, Pancreatic Fluid Collections
Keywords
Acute Pancreatitis, Peripancreatic Fluid Collections, Endoscopic Ultrasound, Endoscopic Drainage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early endoscopic interventions for AP
Arm Type
Experimental
Arm Description
Participants in the intervention group will undergo EUS guided drainage earlier (≤1 weeks) in the disease course.
Arm Title
Standard endoscopic interventions for AP
Arm Type
No Intervention
Arm Description
Participants in the control group will have postponed drainage, preferably until AP progress to the walled-off necrosis stage.
Intervention Type
Procedure
Intervention Name(s)
Early drainage of peripancreatic fluid collections
Intervention Description
Participants will undergo EUS guided drainage earlier (≤1 weeks) in the disease course.
Primary Outcome Measure Information:
Title
Changes in the Bedside Index of Severe Acute Pancreatitis (BISAP)
Description
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.
Time Frame
1-4 week
Title
Number of Participants with New-onset multi-organ failure after intervention
Time Frame
1-4 week
Secondary Outcome Measure Information:
Title
Rates of mortality
Time Frame
6 months
Title
Length of hospital stay
Time Frame
3 months
Title
Length of ICU stays
Time Frame
up to 3 months
Title
Related complications
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baiwen Li
Phone
(+86)021-37798977
Email
muzibowen@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kui Peng
Phone
(+86)021-37798977
Email
drpeng@alumni.sjtu.edu.cn
Facility Information:
Facility Name
Shanghai General Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaodong Sun
Phone
(+86)021-63240090
Email
sfph_edu2@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31791953
Citation
Hines OJ, Pandol SJ. Management of severe acute pancreatitis. BMJ. 2019 Dec 2;367:l6227. doi: 10.1136/bmj.l6227.
Results Reference
background
PubMed Identifier
21478061
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.
Results Reference
background
PubMed Identifier
30146334
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.
Results Reference
background
PubMed Identifier
28050922
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.
Results Reference
background
PubMed Identifier
31479658
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.
Results Reference
background
PubMed Identifier
30279466
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.
Results Reference
background
PubMed Identifier
30568390
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.
Results Reference
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PubMed Identifier
33318376
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.
Results Reference
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PubMed Identifier
23100216
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.
Results Reference
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PubMed Identifier
33496779
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. Erratum In: JAMA. 2021 Jun 15;325(23):2405.
Results Reference
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Early Versus Standard Endoscopic Interventions for Peripancreatic Fluid Collections

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