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

Pancreatitis, Acute Necrotizing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05530772
• Other study ID #: DDRI.1401.008
• Status: Recruiting
• Phase: N/A
• Start date: September 12, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: University of Tehran
• Contact: Mehdi Mohamadnejad, MD
• Phone: +9882415118
• Email: mehdi.nejad[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Necrosis
• Pancreatitis
• Pancreatitis, Acute Necrotizing

Intervention

Device:
• Endoscopic necrosectomy
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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Digestive Diseases Research Institute, Shariati Hospital, North Kargar Ave.,	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
University of Tehran

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (7)

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. — View 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. — View 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. — View 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 O — View 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;14 — View 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, Ka — View 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 ear — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Three months
Secondary	procedure-related adverse events	Comparing procedure-related adverse events between the two groups. Adverse events including bleeding, perforation, secondary infection are compared.	Three months
Secondary	Length of hospital stay	Comparing length of hospital stay between the two groups. Total length of hospital stay is recorded and compared.	Three months
Secondary	Number of necrosectomy sessions	Comparing number of necrosectomy sessions between the two groups	Three months
Secondary	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.	Three months
Secondary	Rate of new onset diabetes mellitus	Comparing rate of new onset diabetes mellitus between the two groups	Three months
Secondary	Mortality rate	Comparing mortality rate between the two groups	Three months
Secondary	Number of patients requiring surgery	Comparing number of patients requiring surgery between the two groups	Three months