Papillary AdenomaERASE-pilotNCT05339607
Endoscopic Resection of Papillary Adenomas; a Novel Treatment Algorithm to Prevent Recurrence - a Pilot-study (ERASE-pilot)
A study testing Thermal ablation of resection margins by STSC and biliary orifice by cystotome. in people with Papillary Adenoma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Recurrence after endoscopic papillectomy is described in up to 33% of the cases (range 12-33%). This leads to re-interventions, a cumulative risk of adverse events, and the need for long-term follow-up. Recurrences most likely originate from either the biliary orifice or lateral resection margins. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Papillary Adenoma
- What is being tested?
- Thermal ablation of resection margins by STSC and biliary orifice by cystotome.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 May 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Papillary adenoma which seems suitable for curative endoscopic resection.
- 18 years or older.
- Capable of providing written and oral informed consent.
Who cannot join
- Patients with intraductal extension of >1 cm beyond the duodenal wall or adenocarcinoma will be excluded since surgical resection is considered the preferred treatment in these cases.
- Failure to place a PD stent in patients with normal pancreatic duct anatomy.
- Refusal to provide informed consent.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC location VUmc
Amsterdam
Jeska Fritzsche, MD
About this study
Recurrence after endoscopic papillectomy is described in up to 33% of the cases (range 12-33%). This leads to re-interventions, a cumulative risk of adverse events, and the need for long-term follow-up. Recurrences most likely originate from either the biliary orifice or lateral resection margins. Ablative methods such as radiofrequency ablation (RFA) and thermal ablation by cystotome inside the bile duct have been described to treat intraductal extension of which the use of a cystotome seems to have a more favorable safety profile. However, no studies focusing on the preventive use of these ablative methods in patient with papillary adenomas have been performed. It is hypothesized that the curative resection rate can be increased and recurrence prevented by using a combination of snare tip soft coagulation (STSC) of the resection margins and thermal ablation by cystotome of the biliary orifice in patients with and without the suggestion of intraductal extension.
Therefore, aim of this study is to assess the safety and feasibility of endoscopic papillectomy combined with thermal ablation of the biliary orifice by cystotome and STSC of the lateral resection margins.
- Conditions
- Papillary Adenoma
- Being tested
- Thermal ablation of resection margins by STSC and biliary orifice by cystotome.
- Keywords
- Endoscopic papillectomy, Recurrence, STSC, Intraductal ablation, Cystotome
- Medical subject headings
- Adenoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal ablation of resection margins by STSC and biliary orifice by cystotome.Other
Patients who are eligible will undergo thermal ablation of the resection margins.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Other: Thermal ablation of resection margins by STSC and biliary orifice by cystotome. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (rate of adverse events)
i.e. pancreatitis, bleeding, cholangitis, perforation, and papillary stenosis.
Measured: During 9 months follow-up
Secondary outcomes (4)
Curative resection rate
Defined as absence of adenomatous residual tissue or recurrence observed in follow-up biopsy sampling.
Measured: 3 and 9 months
Additional yield of EUS prior to resection.
Intraductal growth or invasive growth encountered by EUS and not other imaging
Measured: Prior to intervention.
Effect of hemospray as first modality in case of post procedural bleeding in need of intervention.
Succesfull treatment of post procedural bleeding e.g. no need for re-intervention or transfusion.
Measured: Delayed bleeding is expected not more than 30 days after the procedure
Individual components of the primary outcome.
i.e. rate of adverse events such as pancreatitis, bleeding, cholangitis, perforation, and papillary stenosis.
Measured: During 9 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start5 May 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillary AdenomaStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc
- Responsible party
- Principal investigator, Rogier P. Voermans, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Rogier P Voermans, MD PhD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339607
- Sponsor's protocol ID
- 2021.0684
- Other IDs
- NL79410.029.21
- Acronym
- ERASE-pilot
- Status last verified
- Jan 2023
- First submitted
- 15 Apr 2022
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Resection of Papillary Adenomas; a Novel Treatment Algorithm to Prevent Recurrence - a Pilot-study (ERASE-pilot)
- ClinicalTrials.gov ID
- NCT05339607
- Acronym / sponsor ID
- ERASE-pilot / 2021.0684
- Conditions
- Papillary Adenoma
- Keywords
- Endoscopic papillectomy, Recurrence, STSC, Intraductal ablation, Cystotome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc
- Study start
- 5 May 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recurrence after endoscopic papillectomy is described in up to 33% of the cases (range 12-33%). This leads to re-interventions, a cumulative risk of adverse events, and the need for long-term follow-up. Recurrences most likely originate from either the biliary orifice or lateral resection margins. Ablative methods such as radiofrequency ablation (RFA) and thermal ablation by cystotome inside the bile duct have been described to treat intraductal extension of which the use of a cystotome seems to have a more favorable safety profile. However, no studies focusing on the preventive use of these ablative methods in patient with papillary adenomas have been performed. It is hypothesized that the curative resection rate can be increased and recurrence prevented by using a combination of snare tip soft coagulation (STSC) of the resection margins and thermal ablation by cystotome of the biliary orifice in patients with and without the suggestion of intraductal extension.
Therefore, aim of this study is to assess the safety and feasibility of endoscopic papillectomy combined with thermal ablation of the biliary orifice by cystotome and STSC of the lateral resection margins.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Thermal ablation of resection margins by STSC and biliary orifice by cystotome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Papillary adenoma which seems suitable for curative endoscopic resection.
- 18 years or older.
- Capable of providing written and oral informed consent.
Key exclusion criteria (3 listed)
- Patients with intraductal extension of >1 cm beyond the duodenal wall or adenocarcinoma will be excluded since surgical resection is considered the preferred treatment in these cases.
- Failure to place a PD stent in patients with normal pancreatic duct anatomy.
- Refusal to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermal ablation of resection margins by STSC and biliary orifice by cystotome.Patients who are eligible will undergo thermal ablation of the resection margins. | Other | Intervention |
Primary outcome
Safety (rate of adverse events)
Time frame: During 9 months follow-up
i.e. pancreatitis, bleeding, cholangitis, perforation, and papillary stenosis.
4 secondary outcomes
Curative resection rate
Time frame: 3 and 9 months
Additional yield of EUS prior to resection.
Time frame: Prior to intervention.
Effect of hemospray as first modality in case of post procedural bleeding in need of intervention.
Time frame: Delayed bleeding is expected not more than 30 days after the procedure
Individual components of the primary outcome.
Time frame: During 9 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rogier P Voermans, MD PhD principal investigator
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermal ablation of resection margins by STSC and biliary orifice by cystotome. in people with Papillary Adenoma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeska A Fritzsche, MD (+31204440613, j.a.fritzsche@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (rate of adverse events) (time frame: During 9 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.