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Endoscopic Papillectomy for Ampullary Adenomas (Papillectomy)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03494543
Recruitment Status : Completed
First Posted : April 11, 2018
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Paolo Cecinato, Arcispedale Santa Maria Nuova-IRCCS

Brief Summary:
In this single-center experience we retrospectively evaluated principal clinical outcomes of endoscopic papillectomy in all patients referred to our unit. The same evaluation was then performed dividing sproradic ampullary adenoma from familial adenomatous polyposis associated adenomas, and resulting outcomes were compared.

Condition or disease Intervention/treatment
Ampullary Adenoma Familial Adenomatous Polyposis Procedure: Endoscopic Papillectomy

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Study Type : Observational
Actual Enrollment : 62 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Endoscopic Papillectomy for Ampullary Adenomas: an Italian Single Centre Experience
Actual Study Start Date : January 1, 2005
Actual Primary Completion Date : December 31, 2015
Actual Study Completion Date : December 31, 2017



Intervention Details:
  • Procedure: Endoscopic Papillectomy
    Endoscopic resection of ampullary of Vater neoplasms


Primary Outcome Measures :
  1. technical success [ Time Frame: 24 months ]
    The primary outcome of the study was the technical success of endoscopic papillectomy, considered as achieved when all the following criteria were met: a) complete removal, even in multiple sessions b) absence of residues at histology (histology <= pT1) at the first follow-up; c) recurrence successful treated by endoscopy (not surgery). Technical failure of EP was considered when at least one of the following criteria was met: a) histology> pT1; b) residual adenomatous tissue not suitable of endoscopic resection; c) recurrence treated by surgery


Secondary Outcome Measures :
  1. number of procedures to achieve technical success [ Time Frame: 24 months ]
    number of procedures to achieve technical success

  2. incidence of adverse events [ Time Frame: 24 months ]
    incidence of adverse events

  3. incidence of recurrence [ Time Frame: 24 months ]
    incidence of recurrence

  4. concordance of histology pre- and post endoscopi papillectomy [ Time Frame: 24 months ]
    concordance of histology pre- and post endoscopi papillectomy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All consecutive patients who underwent endoscopi papillectomy because of ampullary tumor at Arcispedale Santa Maria Nuova
Criteria

Inclusion Criteria:

  • Patients with diagnosis of ampullary adenoma on the endoscopic resection specimen and with at least 24 months of follow-up were included in the analysis

Exclusion Criteria:

  • Patients taht underwent endoscopic papillectomy without a diagnosis of adenoma or adenocarcinoma in the specimen

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494543


Sponsors and Collaborators
Arcispedale Santa Maria Nuova-IRCCS
Investigators
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Study Chair: Romano Sassatelli, MD Arcispedale Santa Maria Nuova-IRCCS
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Paolo Cecinato, Principal Investigator, Arcispedale Santa Maria Nuova-IRCCS
ClinicalTrials.gov Identifier: NCT03494543    
Other Study ID Numbers: CORE001
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paolo Cecinato, Arcispedale Santa Maria Nuova-IRCCS:
Ampullary Adenoma
Endoscopic Papillectomy
Familial Adenomatous Polyposis
Additional relevant MeSH terms:
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Adenoma
Adenomatous Polyposis Coli
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenomatous Polyps
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplastic Syndromes, Hereditary
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Intestinal Polyposis
Genetic Diseases, Inborn