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

NCT05339607 | Unknown DMC

• 2 other identifiers: 2021.0684NL79410.029.21
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Endoscopic papillectomy; Recurrence; STSC; Intraductal ablation; Cystotome

Outcome Measures

Primary Outcomes (1)

• Safety (rate of adverse events)

  i.e. pancreatitis, bleeding, cholangitis, perforation, and papillary stenosis.

  During 9 months follow-up

Secondary Outcomes (4)

• Curative resection rate

  3 and 9 months

• Additional yield of EUS prior to resection.

  Prior to intervention.

• Effect of hemospray as first modality in case of post procedural bleeding in need of intervention.

  Delayed bleeding is expected not more than 30 days after the procedure

• Individual components of the primary outcome.

  During 9 months follow-up

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Amsterdam UMC, location VUmc: collaborator

Study Sites (1)

Amsterdam UMC location VUmc

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Adenoma; Recurrence

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rogier P Voermans, MD PhD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeska A Fritzsche, MD

CONTACT

+31204440613; j.a.fritzsche@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: R.P. Voermans MD PhD

Model Details: Pilot study

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: April 21, 2022
• Study Start: May 5, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 2, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)