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

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 Overview

• Status: Recruiting
• Conditions: Papillary Adenoma
• Intervention / Treatment: Other: Thermal ablation of resection margins by STSC and biliary orifice by cystotome.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeska A Fritzsche, MD; Phone Number: +31204440613; Email: j.a.fritzsche@amsterdamumc.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • Amsterdam UMC location VUmc
    • Contact: Jeska Fritzsche, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention	Other: Thermal ablation of resection margins by STSC and biliary orifice by cystotome.; Patients who are eligible will undergo thermal ablation of the resection margins.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety (rate of adverse events)	i.e. pancreatitis, bleeding, cholangitis, perforation, and papillary stenosis.	During 9 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Curative resection rate	Defined as absence of adenomatous residual tissue or recurrence observed in follow-up biopsy sampling.	3 and 9 months
Additional yield of EUS prior to resection.	Intraductal growth or invasive growth encountered by EUS and not other imaging	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.	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.	During 9 months follow-up

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: Amsterdam UMC, location VUmc
• Investigators: Principal Investigator: Rogier P Voermans, MD PhD, Amsterdam UMC, location VUmc

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 5, 2022
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: April 15, 2022
• First Submitted That Met QC Criteria: April 15, 2022
• First Posted (ACTUAL): April 21, 2022

Study Record Updates

• Last Update Posted (ESTIMATE): February 2, 2023
• Last Update Submitted That Met QC Criteria: January 31, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Recurrence; Endoscopic papillectomy; STSC; Intraductal ablation; Cystotome
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Disease Attributes; Adenoma; Recurrence
• Other Study ID Numbers: 2021.0684; NL79410.029.21 (OTHER: CCMO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No