The safety and utility of a novel automated mechanical endoscopic tissue resection tool for endoscopic necrosectomy
| ISRCTN | ISRCTN11791921 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11791921 |
| Protocol serial number | MEC-2018-1426 |
| Sponsor | Erasmus University Medical Center |
| Funder | Investigator initiated and funded |
- Submission date
- 27/09/2018
- Registration date
- 16/10/2018
- Last edited
- 18/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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
Contact information
Scientific
Erasmus Medical Center
Department of Gastroenterology and Hepatology
Doctor Molewaterplein 40
Rotterdam
3015 GD
Netherlands
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective multicenter study |
| Secondary study design | Case series |
| Scientific title | Safety and efficacy of the EndoRotor® for endoscopic treatment of patients with acute necrotizing pancreatitis |
| Study acronym | EETAP |
| Study objectives | The EndoRotor is an effective endoscopic tool for the removal of pancreatic necrosis in patients with acute necrotizing pancreatitis. |
| Ethics approval(s) | Erasmus University Medical Center Ethics Committee, 17/09/2018, ref: MEC-2018-1426 |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
1. The incidence of complications associated with the endoscopic treatment, evaluated during the procedure and after the procedure during admission |
| Completion date | 01/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 10 |
| Key inclusion criteria | 1. Male and female 2. Aged 18 years or older 3. Acute necrotizing pancreatitis |
| Key exclusion criteria | Inability to undergo endoscopic treatment due to comorbidity |
| Date of first enrolment | 01/01/2017 |
| Date of final enrolment | 27/07/2018 |
Locations
Countries of recruitment
- Germany
- Netherlands
Study participating centre
Rotterdam
3015 GD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | 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) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | preliminary results | 21/02/2020 | 13/07/2020 | Yes | No |
Editorial Notes
18/01/2021: Internal review.
13/07/2020: Publication reference added.
11/12/2019: The intention to publish date has been changed from 01/12/2018 to 01/01/2020.
