Predictors of Therapeutic Success and Adverse Events in Endoscopic Ampullectomy

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.

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Key information

Conditions

Ampulla of Vater Adenoma Ampulla of Vater Disease (Benign/Malignancy) Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Therapeutic success

Time frame: 1 year
- Rate of adenoma recurrence after endoscopic resection of ampullary adenomas
Safety outcomes

Time frame: 1 year
- Rate of adverse events related to endoscopic resection of ampullary adenomas

Secondary outcomes

Prophylaxis

Time frame: 1 year
- Comparison of the post-ampullectomy acute pancreatitis incidence with different kinds of prophylaxis
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

Study contacts

Contact information is provided by the study sponsor or research team.

Paulo Salgueiro, MD, PhD

CONTACT

[email protected]

00351222077500

Sponsors and collaborators

Lead sponsor

Universidade do Porto

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Oct 18, 2024
Registry last updated: Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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