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

Primary Purpose

Papillary Adenoma

Status

Recruiting

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Papillary Adenoma focused on measuring Endoscopic papillectomy, Recurrence, STSC, Intraductal ablation, Cystotome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Amsterdam UMC location VUmcRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Outcomes

Primary Outcome Measures

Safety (rate of adverse events)

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

Secondary Outcome Measures

Curative resection rate

Defined as absence of adenomatous residual tissue or recurrence observed in follow-up biopsy sampling.

Additional yield of EUS prior to resection.

Intraductal growth or invasive growth encountered by EUS and not other imaging

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.

Individual components of the primary outcome.

i.e. rate of adverse events such as pancreatitis, bleeding, cholangitis, perforation, and papillary stenosis.

Full Information

NCT ID

NCT05339607

First Posted

April 15, 2022

Last Updated

January 31, 2023

Sponsor

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

Collaborators

Amsterdam UMC, location VUmc

1. Study Identification

Unique Protocol Identification Number

NCT05339607

Brief Title

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

Acronym

ERASE-pilot

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 5, 2022 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

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

Collaborators

Amsterdam UMC, location VUmc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Papillary Adenoma

Keywords

Endoscopic papillectomy, Recurrence, STSC, Intraductal ablation, Cystotome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Pilot study

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety (rate of adverse events)

Description

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

Time Frame

During 9 months follow-up

Secondary Outcome Measure Information:

Title

Curative resection rate

Description

Defined as absence of adenomatous residual tissue or recurrence observed in follow-up biopsy sampling.

Time Frame

3 and 9 months

Title

Additional yield of EUS prior to resection.

Description

Intraductal growth or invasive growth encountered by EUS and not other imaging

Time Frame

Prior to intervention.

Title

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

Description

Succesfull treatment of post procedural bleeding e.g. no need for re-intervention or transfusion.

Time Frame

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

Title

Individual components of the primary outcome.

Description

i.e. rate of adverse events such as pancreatitis, bleeding, cholangitis, perforation, and papillary stenosis.

Time Frame

During 9 months follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jeska A Fritzsche, MD

Phone

+31204440613

j.a.fritzsche@amsterdamumc.nl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rogier P Voermans, MD PhD

Organizational Affiliation

Amsterdam UMC, location VUmc

Official's Role

Principal Investigator

Facility Information:

Facility Name

Amsterdam UMC location VUmc

City

Amsterdam

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jeska Fritzsche, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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