Condition category
Digestive System
Date applied
27/09/2018
Date assigned
16/10/2018
Last edited
16/10/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Acute pancreatitis is a sudden inflammation of the pancreas. The most common cause of acute pancreatitis is gallstones, other known causes include amongst others alcohol use, trauma, medication and high lipid (fat) levels. In 80% of patients pancreatitis is mild and settles within a week or two. In about 20% of patients the pancreatitis becomes severe. Parts of the pancreas may die (necrose). When the necrosis becomes infected, treatment is virtually always necessary. Infected necrosis is associated with a mortality (death rate) of 20% and many other complications. A lot of studies have been performed to optimize the treatment strategies for these patients. Endoscopic drainage of the abscess and necrosectomy (actively remove the necrotic tissue) have been shown to be effective. However, currently no effective tool is available to remove the necrotic tissue. The aim of this study is to evaluate a novel tool (the EndoRotor) to endoscopically remove necrotic tissue.

Who can participate?
Patients aged 18 and over with acute necrotizing pancreatitis

What does the study involve?
Patients undergo endoscopic drainage and necrosectomy. The only difference is that the necrosectomy is performed using the EndoRotor. Technical success is defined as complete removal of the pancreatic necrosis at the discretion of the treating physician.

What are the possible benefits and risks of participating?
There are no additional risks with participating in this study besides known risks for necrosectomy. Possible benefits include fewer procedures to achieve complete removal of pancreatic necrosis and shortened length of hospital stay.

Where is the study run from?
Erasmus University Medical Center (the Netherlands) and Sana Klinikum Offenbach (Germany)

When is the study starting and how long is it expected to run for?
October 2016 to December 2018

Who is funding the study?
Erasmus University Medical Center (Netherlands)

Who is the main contact?
Dr A.D. Koch

Trial website

Contact information

Type

Scientific

Primary contact

Dr A.D. Koch

ORCID ID

Contact details

Erasmus Medical Center
Department of Gastroenterology and Hepatology
Doctor Molewaterplein 40
Rotterdam
3015 GD
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MEC-2018-1426

Study information

Scientific title

Safety and efficacy of the EndoRotorĀ® for endoscopic treatment of patients with acute necrotizing pancreatitis

Acronym

EETAP

Study hypothesis

The EndoRotor is an effective endoscopic tool for the removal of pancreatic necrosis in patients with acute necrotizing pancreatitis.

Ethics approval

Erasmus University Medical Center Ethics Committee, 17/09/2018, ref: MEC-2018-1426

Study design

Prospective multicenter study

Primary study design

Observational

Secondary study design

Case series

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Acute necrotizing pancreatitis

Intervention

Patients (male and female, aged over 18 years) were treated for (infected) necrotizing pancreatitis. Patients underwent transluminal drainage followed by direct endoscopic necrosectomy using the EndoRotor. Details on the procedure with the EndoRotor were identified; duration of the procedure, number of interventions to completely remove necrotic tissue, and procedural complications. Patients were followed during their hospitalization.

Intervention type

Device

Phase

Drug names

Primary outcome measure

Technical success: this was defined as complete removal of the pancreatic necrosis at the discretion of the treating physician. This was disregarding the number of necessary interventions.

Secondary outcome measures

1. The incidence of complications associated with the endoscopic treatment, evaluated during the procedure and after the procedure during admission
2. Total number of interventions to achieve complete removal of pancreatic necrosis

Overall trial start date

01/10/2016

Overall trial end date

01/12/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Male and female
2. Aged 18 years or older
3. Acute necrotizing pancreatitis

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10

Participant exclusion criteria

Inability to undergo endoscopic treatment due to comorbidity

Recruitment start date

01/01/2017

Recruitment end date

27/07/2018

Locations

Countries of recruitment

Germany, Netherlands

Trial participating centre

Erasmus University Medical Center
Dr. Molewaterplein 40
Rotterdam
3015 GD
Netherlands

Sponsor information

Organisation

Erasmus University Medical Center

Sponsor details

Erasmus Medical Center
Department of Gastroenterology and Hepatology
Dr. Molewaterplein 40
Rotterdam
3015 GD
Netherlands

Sponsor type

Hospital/treatment centre

Website

www.erasmusmc.nl

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned submission of manuscript to a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr A.D. Koch (a.d.koch@erasmusmc.nl)

Intention to publish date

01/12/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes