Endoscopic Resection of Papillary Adenomas; a Novel Treatment Algorithm to Prevent Recurrence - a Pilot-study (ERASE-pilot)

NCT ID: NCT05339607

Last Updated: 2023-02-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-05
• Study Completion Date: 2023-12-31

Brief 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. 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Group Type: EXPERIMENTAL

Thermal ablation of resection margins by STSC and biliary orifice by cystotome.

Intervention Type: OTHER

Patients who are eligible will undergo thermal ablation of the resection margins.

Interventions

Thermal ablation of resection margins by STSC and biliary orifice by cystotome.

Patients who are eligible will undergo thermal ablation of the resection margins.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Papillary adenoma which seems suitable for curative endoscopic resection.
• 18 years or older.
• Capable of providing written and oral informed consent.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amsterdam UMC, location VUmc

OTHER

Sponsor Role: collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: lead

Responsible Party

Rogier P. Voermans

R.P. Voermans MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rogier P Voermans, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, location VUmc

Locations

Amsterdam UMC location VUmc

Amsterdam, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Jeska A Fritzsche, MD

Role: CONTACT

j.a.fritzsche@amsterdamumc.nl

+31204440613

Facility Contacts

Jeska Fritzsche, MD

Role: primary

Other Identifiers

NL79410.029.21

Identifier Type: OTHER

Identifier Source: secondary_id

2021.0684

Identifier Type: -

Identifier Source: org_study_id