Predictors of Therapeutic Success and Adverse Events in Endoscopic Ampullectomy

October 16, 2024 updated by: Paulo Sérgio Durão Salgueiro, Universidade do Porto

Although ampullary tumors are rare (representing 0.6-0.8 % of all digestive cancers), their estimated incidence has increased in recent years (<1 per 100 000 per year). Most noninvasive ampullary tumors of the major papilla occur as sporadic and asymptomatic lesions, detected during conventional upper endoscopy performed for another indication.

Nonetheless, they can present with jaundice (17%), pain (14%), pancreatitis (4%), cholangitis (1%), and can be associated with common bile duct stones (up to 38%). Resection of ampullary adenomas is warranted to prevent malignant progression. The most recent European Society of Gastrointestinal Endoscopy (ESGE) recommend endoscopic ampullectomy as the standard of care approach for ampullary adenomas without intraductal extension, due to excellent outcomes of technical and clinical success (high complete and curative resection rates of 94% and 87%, respectively), with lower morbidity and recurrence rates. This procedure as a low rate of mortality (of 0.4%), but the rate of adverse events can exceed 20%. The most frequent adverse events are acute pancreatitis (12%), intraprocedural and/or delayed bleeding (11%), perforation (3%), cholangitis (3%), ampullary stenosis (2.5%). Also there is a high recurrence rate of up to one third after endoscopic resection; up to two thirds are identified at the first follow-up endoscopy, requiring additional endoscopic resection or surgery.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

The relevance of the study is to assess the predictors for therapeutic success, adverse events and recurrence after endoscopic ampullectomy is of paramount importance to develop expertise in this challenging procedure.

The occurrence of adverse events after endoscopic ampullectomy carries a significant impact on the prognosis and recovery, possibly limiting a broader proficiency in this procedure. Thus, identifying significant predictors is crucial to more accurately select the patients and to evolve strategies to prevent and minimize the incidence and severity of adverse events.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive adult patients submihed to endoscopic resection of an ampullary adenoma in each of the participating center (ULS de Santo António - Porto; ULS São João - Porto)

Description

Inclusion Criteria:

  • Adult patients (≥18 years) submitted to endoscopic resection of an ampullary adenoma with the following features were included:

    • lesions up to 30 mm (including with laterally spreading component)
    • with low-grade or high-grade dysplasia on preprocedural histology
    • with no intraductal extension
    • with no evidence of invasive malignancy on endoscopic assessment (including endoscopic features including hard consistency, friable or ulcera:ve surface and spontaneous bleeding)
  • A minimum follow-up period of one year afer endoscopic ampullary resection.

Exclusion Criteria:

  • Patients with lesions with the following features were excluded:

    • intraductal extension
    • evidence of invasive malignancy
    • other non-adenomatous lesions
  • Patients who underwent endoscopic resection or surgical ampullectomy prior to enrollment
  • Patients with a follow-up of less than a year after endoscopic ampullary resection
  • Patients with pancreas divisum.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Endoscopic ampullectomy
Consecutive adult patients submitted to endoscopic resection of an ampullary adenoma in each of the participating center for which endoscopic ampullectomy was performed from 1st January 2019 to 31th December will be included. Clinical and demographic data related to the patient, and data pertaining to the ampullary lesion and the endoscopic ampullectomy procedure will be obtained by reviewing the medical records of each participating center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Therapeutic success
Time Frame: 1 year
- Rate of adenoma recurrence after endoscopic resection of ampullary adenomas
1 year
Safety outcomes
Time Frame: 1 year
- Rate of adverse events related to endoscopic resection of ampullary adenomas
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prophylaxis
Time Frame: 1 year
- Comparison of the post-ampullectomy acute pancreatitis incidence with different kinds of prophylaxis
1 year
Risk factors
Time Frame: 1 year
To perform a multivariate analysis of patient, lesion and procedure characteristics that correlate with the incidence of adverse events
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade do Porto

Investigators

  • Principal Investigator: Paulo Salgueiro, MD, PhD, Universidade do Porto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

October 14, 2024

First Submitted That Met QC Criteria

October 16, 2024

First Posted (Actual)

October 18, 2024

Study Record Updates

Last Update Posted (Actual)

October 18, 2024

Last Update Submitted That Met QC Criteria

October 16, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 112233

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Not decided yet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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