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Immediate vs. On-demand Endoscopic Necrosectomy in Infected Walled-off Pancreatic Necrosis

Primary Purpose

Pancreatitis, Acute Necrotizing

Status
Recruiting
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Endoscopic necrosectomy
Sponsored by
University of Tehran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatitis, Acute Necrotizing

Eligibility Criteria

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

Inclusion Criteria:

  • Documented history of acute pancreatitis
  • Necrotic collection with partial or complete wall diagnosed on CT or MRI
  • Necrotic collection of any size with any number of loculations with more than 20% of solid/necrotic component
  • Necrotic collection is accessible and amenable for EUS-guided drainage
  • Age >= 18 years
  • Suspected or confirmed infection in the necrotic collection
  • The patient understands and accepts to sign the informed consent.

Exclusion Criteria:

  • Irreversible coagulopathy with INR>1.5 or platelet counts <50,000
  • Necrotic collection is not accessible for EUS-guided drainage
  • Females who are pregnant
  • Previous intervention (e,g, percutaneous drainage, or surgery) is performed for the patient

Sites / Locations

  • Digestive Diseases Research Institute, Shariati Hospital, North Kargar Ave.,Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediate endoscopic Necrosectomy

On-demand endoscopic necrosectomy

Arm Description

The subject will have endoscopic necrosectomy at the time of the EUS-guided transmural stent placement. The necrotic collection is identified with endoscopic ultrasonography (EUS). Transmural placement of stent under EUS guidance is performed. The type of stent is at the discretion of endoscopist. It could be either lumen apposing metallic stent or double pigtail plastic stent. Immediately after stent placement, the cystoenterostomy track is dilated with a 15 mm through the scope (TTS) balloon. Then, direct endoscopic necrosectomy is performed with CO2 insufflation. The duration of necrosectomy will be 30 to 90 minutes. If complete clearance of the cavity is achieved before 30 minutes, the duration of necrosectomy may be less than 30 minutes in the given session. Also, if any complication occurs during necrosectomy, appropriate management will be done, and the procedure may be concluded earlier.

The subject will have EUS-guided transmural drainage of the necrotic collection The necrotic collection is identified with endoscopic ultrasonography (EUS). Transmural placement of stent under EUS guidance is performed. The type of stent is at the discretion of endoscopist. It could be either lumen apposing metallic stent or double pigtail plastic stent. In this group, endoscopic necrosectomy is not performed at the time of index procedure. Such patients may undergo endoscopic necrosectomy during follow up if clinically indicated.

Outcomes

Primary Outcome Measures

Clinical success rate
Clinical success rate is compared between the two groups. Clinical success is defined as complete resolution of WOPN without residual fluid component along with resolution of symptoms three months after stent placement

Secondary Outcome Measures

procedure-related adverse events
Comparing procedure-related adverse events between the two groups. Adverse events including bleeding, perforation, secondary infection are compared.
Length of hospital stay
Comparing length of hospital stay between the two groups. Total length of hospital stay is recorded and compared.
Number of necrosectomy sessions
Comparing number of necrosectomy sessions between the two groups
Total duration of necrosectomies (in miniute)
Comparing total duration of necrosectomies (in miniute) between the two groups. Total duration of necrosectomies (in miniute) in all necroectomy sessions is recorded and compared between the two groups.
Rate of new onset diabetes mellitus
Comparing rate of new onset diabetes mellitus between the two groups
Mortality rate
Comparing mortality rate between the two groups
Number of patients requiring surgery
Comparing number of patients requiring surgery between the two groups

Full Information

First Posted
September 2, 2022
Last Updated
May 27, 2023
Sponsor
University of Tehran
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1. Study Identification

Unique Protocol Identification Number
NCT05530772
Brief Title
Immediate vs. On-demand Endoscopic Necrosectomy in Infected Walled-off Pancreatic Necrosis
Official Title
Immediate Endoscopic Necrosectomy vs. On-demand Necroectomy in Infected Walled-off Pancreatic Necrosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tehran

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Acute pancreatitis is one of the most common diagnoses made in gastroenterology wards worldwide which causes a great deal of pain and expense along with fatal complications. Approximately, 10-20% of patients progress to necrotizing pancreatitis that result in significant morbidity and mortality. Initial conservative management may be feasible in necrotizing pancreatitis, however the majority of patients with infected necrosis or persistent symptoms will eventually require a drainage procedure. Drainage procedures for necrotizing pancreatitis include open surgery, minimally invasive surgery, percutaneous drainage, and endoscopic drainage. In the recent years, minimally invasive approaches have largely replaced open surgical necrosectomy. Endoscopic drainage of walled off pancreatic necrosis involves creation of a transmural fistula between the enteral lumen and WOPN cavity with stent placement under endoscopic ultrasound (EUS) guidance. Furthermore, direct endoscopic necrosectomy can be performed through the fistula track. The best timing for endoscopic necrosectomy is not yet defined. A recent retrospective study suggested that immediate necrosectomy after stent placement results in earlier resolution of WOPN with fewer sessions of endoscopic necrosectomy. The aim of this study is to compare immediate vs. on-demand endoscopic necrosectomy in patients with infected WOPN who undergo EUS-guided transmural drainage of WOPN.
Detailed Description
Acute pancreatitis is one of the most common diagnoses made in gastroenterology wards worldwide which causes a great deal of pain and expense along with fatal complications (1). The incidence of acute pancreatitis is trending upward in the United States with $2.6 billion annual health care costs (2). While most patients present with mild and interstitial form of pancreatitis, 10-20% of patients progress to necrotizing pancreatitis that result in significant morbidity and mortality (3). Initial conservative management may be feasible in necrotizing pancreatitis (4), however the majority of patients with infected necrosis or persistent symptoms will eventually require a drainage procedure (5). Drainage procedures for necrotizing pancreatitis include open surgery, minimally invasive surgery, percutaneous drainage, and endoscopic drainage. Drainage procedures are typically postponed for several weeks until the necrotic cavity becomes walled off which is called walled off pancreatic necrosis (WOPN). In the recent years, minimally invasive approaches have largely replaced open surgical necrosectomy (6). Endoscopic drainage of walled off pancreatic necrosis involves creation of a transmural fistula between the enteral lumen and WOPN cavity with stent placement under endoscopic ultrasound (EUS) guidance. Furthermore, direct endoscopic necrosectomy can be performed through the fistula track. The best timing for endoscopic necrosectomy is not yet defined. A recent retrospective study suggested that immediate necrosectomy after stent placement results in earlier resolution of WOPN with fewer sessions of endoscopic necrosectomy (7). The aim of this study is to compare immediate vs. on-demand endoscopic necrosectomy in patients with infected WOPN who undergo EUS-guided transmural drainage of WOPN. Infected necrosis is diagnosed with one of the following criteria in patients with WOPN three weeks after onset of acute pancreatitis (8): A. Positive Gram's stain or culture from a fine-needle aspiration; B. the presence of gas within pancreatic and peripancreatic necrosis on contrast-enhanced CT scan; C. Presence of two inflammatory variables (temperature >38.5°C or elevated C-reactive protein levels or leukocyte counts) in the absence of another focus of infection (other than infected necrosis) ; D. Presence of persistent organ failure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis, Acute Necrotizing

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Immediate endoscopic Necrosectomy
Arm Type
Experimental
Arm Description
The subject will have endoscopic necrosectomy at the time of the EUS-guided transmural stent placement. The necrotic collection is identified with endoscopic ultrasonography (EUS). Transmural placement of stent under EUS guidance is performed. The type of stent is at the discretion of endoscopist. It could be either lumen apposing metallic stent or double pigtail plastic stent. Immediately after stent placement, the cystoenterostomy track is dilated with a 15 mm through the scope (TTS) balloon. Then, direct endoscopic necrosectomy is performed with CO2 insufflation. The duration of necrosectomy will be 30 to 90 minutes. If complete clearance of the cavity is achieved before 30 minutes, the duration of necrosectomy may be less than 30 minutes in the given session. Also, if any complication occurs during necrosectomy, appropriate management will be done, and the procedure may be concluded earlier.
Arm Title
On-demand endoscopic necrosectomy
Arm Type
Active Comparator
Arm Description
The subject will have EUS-guided transmural drainage of the necrotic collection The necrotic collection is identified with endoscopic ultrasonography (EUS). Transmural placement of stent under EUS guidance is performed. The type of stent is at the discretion of endoscopist. It could be either lumen apposing metallic stent or double pigtail plastic stent. In this group, endoscopic necrosectomy is not performed at the time of index procedure. Such patients may undergo endoscopic necrosectomy during follow up if clinically indicated.
Intervention Type
Device
Intervention Name(s)
Endoscopic necrosectomy
Intervention Description
Initially, a tract is created between the stomach or duodenum with the walled-off pancreatic necrotic collection through placement of a stent. Then, the endosocpe is entered the necrotic cavity with CO2 insufflation, and the necrotic materials are removed with snare, grasper, or suctioning.
Primary Outcome Measure Information:
Title
Clinical success rate
Description
Clinical success rate is compared between the two groups. Clinical success is defined as complete resolution of WOPN without residual fluid component along with resolution of symptoms three months after stent placement
Time Frame
Three months
Secondary Outcome Measure Information:
Title
procedure-related adverse events
Description
Comparing procedure-related adverse events between the two groups. Adverse events including bleeding, perforation, secondary infection are compared.
Time Frame
Three months
Title
Length of hospital stay
Description
Comparing length of hospital stay between the two groups. Total length of hospital stay is recorded and compared.
Time Frame
Three months
Title
Number of necrosectomy sessions
Description
Comparing number of necrosectomy sessions between the two groups
Time Frame
Three months
Title
Total duration of necrosectomies (in miniute)
Description
Comparing total duration of necrosectomies (in miniute) between the two groups. Total duration of necrosectomies (in miniute) in all necroectomy sessions is recorded and compared between the two groups.
Time Frame
Three months
Title
Rate of new onset diabetes mellitus
Description
Comparing rate of new onset diabetes mellitus between the two groups
Time Frame
Three months
Title
Mortality rate
Description
Comparing mortality rate between the two groups
Time Frame
Three months
Title
Number of patients requiring surgery
Description
Comparing number of patients requiring surgery between the two groups
Time Frame
Three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented history of acute pancreatitis Necrotic collection with partial or complete wall diagnosed on CT or MRI Necrotic collection of any size with any number of loculations with more than 20% of solid/necrotic component Necrotic collection is accessible and amenable for EUS-guided drainage Age >= 18 years Suspected or confirmed infection in the necrotic collection The patient understands and accepts to sign the informed consent. Exclusion Criteria: Irreversible coagulopathy with INR>1.5 or platelet counts <50,000 Necrotic collection is not accessible for EUS-guided drainage Females who are pregnant Previous intervention (e,g, percutaneous drainage, or surgery) is performed for the patient
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mehdi Mohamadnejad, MD
Phone
+9882415118
Email
mehdi.nejad@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Morteza Hassanzadeh, MD
Phone
+9882415118
Email
drmhxim@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alireza Delavari, MD
Organizational Affiliation
Chair, Digestive dieseases research institute, Tehran University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Digestive Diseases Research Institute, Shariati Hospital, North Kargar Ave.,
City
Tehran
ZIP/Postal Code
1411713135
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehdi Mohamadnejad, MD
Phone
+982182415118

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25616312
Citation
Lankisch PG, Apte M, Banks PA. Acute pancreatitis. Lancet. 2015 Jul 4;386(9988):85-96. doi: 10.1016/S0140-6736(14)60649-8. Epub 2015 Jan 21. Erratum In: Lancet. 2015 Nov 21;386(10008):2058.
Results Reference
result
PubMed Identifier
26327134
Citation
Peery AF, Crockett SD, Barritt AS, Dellon ES, Eluri S, Gangarosa LM, Jensen ET, Lund JL, Pasricha S, Runge T, Schmidt M, Shaheen NJ, Sandler RS. Burden of Gastrointestinal, Liver, and Pancreatic Diseases in the United States. Gastroenterology. 2015 Dec;149(7):1731-1741.e3. doi: 10.1053/j.gastro.2015.08.045. Epub 2015 Aug 29.
Results Reference
result
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
result
PubMed Identifier
23063972
Citation
Mouli VP, Sreenivas V, Garg PK. Efficacy of conservative treatment, without necrosectomy, for infected pancreatic necrosis: a systematic review and meta-analysis. Gastroenterology. 2013 Feb;144(2):333-340.e2. doi: 10.1053/j.gastro.2012.10.004. Epub 2012 Oct 12.
Results Reference
result
PubMed Identifier
32891214
Citation
Boxhoorn L, Voermans RP, Bouwense SA, Bruno MJ, Verdonk RC, Boermeester MA, van Santvoort HC, Besselink MG. Acute pancreatitis. Lancet. 2020 Sep 5;396(10252):726-734. doi: 10.1016/S0140-6736(20)31310-6. Erratum In: Lancet. 2021 Nov 6;398(10312):1686.
Results Reference
result
PubMed Identifier
20410514
Citation
van Santvoort HC, Besselink MG, Bakker OJ, Hofker HS, Boermeester MA, Dejong CH, van Goor H, Schaapherder AF, van Eijck CH, Bollen TL, van Ramshorst B, Nieuwenhuijs VB, Timmer R, Lameris JS, Kruyt PM, Manusama ER, van der Harst E, van der Schelling GP, Karsten T, Hesselink EJ, van Laarhoven CJ, Rosman C, Bosscha K, de Wit RJ, Houdijk AP, van Leeuwen MS, Buskens E, Gooszen HG; Dutch Pancreatitis Study Group. A step-up approach or open necrosectomy for necrotizing pancreatitis. N Engl J Med. 2010 Apr 22;362(16):1491-502. doi: 10.1056/NEJMoa0908821.
Results Reference
result
PubMed Identifier
29882517
Citation
Yan L, Dargan A, Nieto J, Shariaha RZ, Binmoeller KF, Adler DG, DeSimone M, Berzin T, Swahney M, Draganov PV, Yang DJ, Diehl DL, Wang L, Ghulab A, Butt N, Siddiqui AA. Direct endoscopic necrosectomy at the time of transmural stent placement results in earlier resolution of complex walled-off pancreatic necrosis: Results from a large multicenter United States trial. Endosc Ultrasound. 2019 May-Jun;8(3):172-179. doi: 10.4103/eus.eus_108_17.
Results Reference
result

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Immediate vs. On-demand Endoscopic Necrosectomy in Infected Walled-off Pancreatic Necrosis

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