Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NL79410.029.21 | Other Identifier | CCMO |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Amsterdam UMC, location VUmc | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety (rate of adverse events) | i.e. pancreatitis, bleeding, cholangitis, perforation, and papillary stenosis. | During 9 months follow-up |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeska A Fritzsche, MD | Contact | +31204440613 | j.a.fritzsche@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Rogier P Voermans, MD PhD | Amsterdam UMC, location VUmc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC location VUmc | Recruiting | Amsterdam | Netherlands |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Pilot study
Not provided
Not provided
Not provided
Not provided
| 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 |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided