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

Not Applicable

Recruiting

• Conditions: Papillary Adenoma
• Interventions: Other: Thermal ablation of resection margins by STSC and biliary orifice by cystotome.

• Registration Number: NCT05339607
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-15
• Study First Submitted QC: 2022-04-15
• Study First Posted: 2022-04-21
• Study Start: 2022-05-05
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-31
• Last Update Posted: 2023-02-02
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Thermal ablation of resection margins by STSC and biliary orifice by cystotome.	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Curative resection rate	3 and 9 months	Defined as absence of adenomatous residual tissue or recurrence observed in follow-up biopsy sampling.
Additional yield of EUS prior to resection.	Prior to intervention.	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.	Delayed bleeding is expected not more than 30 days after the procedure	Succesfull treatment of post procedural bleeding e.g. no need for re-intervention or transfusion.
Individual components of the primary outcome.	During 9 months follow-up	i.e. rate of adverse events such as pancreatitis, bleeding, cholangitis, perforation, and papillary stenosis.

Trial Locations

Locations (1)

Amsterdam UMC location VUmc; 🇳🇱 Amsterdam, Netherlands