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

Study Overview
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Brief Summary
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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.

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

Conditions
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Papillary Adenoma

Intervention / Treatment
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* Other: Thermal ablation of resection margins by STSC and biliary orifice by cystotome.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Other: Thermal ablation of resection margins by STSC and biliary orifice by cystotome.<br>* Patients who are eligible will undergo thermal ablation of the resection margins.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic papillectomy, Recurrence, STSC, Intraductal ablation, Cystotome