Clinical trial NCT06648746: Predictors of Therapeutic Success and Adverse Events in Endoscopic Ampullectomy
Official title: Predictors of Therapeutic Success and Adverse Events in Endoscopic Ampullectomy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ampulla of Vater Adenoma
Ampulla of Vater Disease (Benign/Malignancy)
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
First posted: 2024-10-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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)

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Therapeutic success
timeFrame: 1 year
measure: Safety outcomes
timeFrame: 1 year
Secondary outcomes:
measure: Prophylaxis
timeFrame: 1 year
measure: Risk factors
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Universidade do Porto
name: Paulo Salgueiro, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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