Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648746
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-14
Brief Title:
Predictors of Therapeutic Success and Adverse Events in Endoscopic Ampullectomy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Predictors of Therapeutic Success and Adverse Events in Endoscopic Ampullectomy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Although ampullary tumors are rare representing 06-08 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 04 but the rate of adverse events can exceed 20 The most frequent adverse events are acute pancreatitis 12 intraprocedural andor delayed bleeding 11 perforation 3 cholangitis 3 ampullary stenosis 25 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
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 04 but the rate of adverse events can exceed 20 The most frequent adverse events are acute pancreatitis 12 intraprocedural andor delayed bleeding 11 perforation 3 cholangitis 3 ampullary stenosis 25 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None