Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409741
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-05-05
Brief Title:
PrEveNtion of Biliary Events After Acute Pancreatitis In NonSUrgicaL pAtients PENINSULA Trial
Sponsor:
Hospital General Universitario de Alicante
Organization:
Hospital General Universitario de Alicante
Study Overview
Official Title:
PrEveNtion of Biliary Events After Acute Pancreatitis in NonSUrgicaL pAtients Sphincterotomy vs Conservative Treatment Multicenter Randomized Clinical Trial PENINSULA Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PENINSULA
Brief Summary:
Acute pancreatitis AP is a common condition and its main etiology is biliary Cholecystectomy is the standard preventive treatment for recurrence of AP after admission However due to an increasingly older population and increased patient comorbidity it is not always a possible option these days If cholecystectomy is not performed there is a significant risk for a recurrence of a biliopancreatic event pancreatitis biliary colic choledocholithiasis cholecystitis or cholangitis of around 50 in the first year This can lead to further episodes of pain patient readmissions and a reduced quality of life Additionally frequent readmissions can create a high cost burden on the health system Currently certain clinical guidelines propose biliary sphincterotomy as an alternative for patients in whom surgery is not feasible However this recommendation is based on retrospective studies with small sample size and the adherence to this recommendation is very low 12-23
The goal of this clinical trial is to evaluate the recurrence of biliopancreatic events in the first year after admission for an acute biliary pancreatitis episode in patients that are not suitable for surgery The main question it aims to answer is
Does biliary sphincterotomy prevent biliopancreatic event recurrence in non surgical patients after an episode of biliary acute pancreatitis
Researchers will compare biliary sphincterotomy vs conservative treatment to see if there is a reduction in biliopancreatic events during the first year after admission for acute pancreatitis in non surgical patients
Participants will be randomized to conservative treatment or biliary sphincterotomy and will be followed up for one year at 1 month 6 months and 12 months to evaluate recurrence of BPE readmissions quality of life and mortality Security of the technique will also be assessed in this specific population
The goal of this clinical trial is to evaluate the recurrence of biliopancreatic events in the first year after admission for an acute biliary pancreatitis episode in patients that are not suitable for surgery The main question it aims to answer is
Does biliary sphincterotomy prevent biliopancreatic event recurrence in non surgical patients after an episode of biliary acute pancreatitis
Researchers will compare biliary sphincterotomy vs conservative treatment to see if there is a reduction in biliopancreatic events during the first year after admission for acute pancreatitis in non surgical patients
Participants will be randomized to conservative treatment or biliary sphincterotomy and will be followed up for one year at 1 month 6 months and 12 months to evaluate recurrence of BPE readmissions quality of life and mortality Security of the technique will also be assessed in this specific population
Detailed Description:
Our working hypothesis is that endoscopic treatment with biliary sphincterotomy will reduce the number of biliopancreatic events compared to conservative treatment in patients with non-operable biliary acute pancreatitis AP due to a high surgical risk or in those patients who refuse surgery
The primary aim is to assess the recurrence of the combined variable of biliopancreatic events BPE biliary colic cholangitis choledocholithiasis acute cholecystitis or AP of the endoscopic sphincterotomy strategy during the follow-up time after diagnosis of AP of biliary origin in inoperable patients with respect to conservative treatment
This is a randomized multicenter open-label nationwide intention-to-treat clinical trial Patients will be randomized 11 to the two treatment groups stratified by center and AP severity
Centers considered to participate as collaborators centers will need to have an endoscopy unit with ERCP availability that perform more than 150 ERCPsyear and endoscopists trained in this technique Patient inclusion and exclusion criteria is specified in a specific section of the protocol
For the inclusion of patients after diagnosis of biliary AP BAP and having ruled cholecystectomy as a possibility for the patient because of high surgical risk after evaluation by surgery or anesthesia or patients refusal to undergo cholecystectomy the absence of choledocholithiasis will be confirmed by MRCP or EUS
If the patient fulfills these requirements in addition to all the previous inclusion criteria and none of the exclusion criteria and agrees to participate in the study and signs the informed consent the patient will be included and randomized
This randomization will be carried out in each of the collaborating centers and the patient will be assigned to a treatment group following the random assignment method
The randomization of patients to each of the treatment groups will be carried out centrally by the REDCap software REDCap is a program that offers an online electronic data collection notebook It will be stratified by center and by severity of BAP mild moderate or severe according to the Revised Atlanta Classification
Patients will be randomized to receive ERCP biliary sphincterotomy or conservative management 63 patients will be allocated to each group An interim safety analysis is proposed which will be evaluated by an independent committee of 3 persons with experience in complications associated with ERCP and knowledge of biliopancreatic pathology once 50 of the sample reaches 6 months of follow-up In the event that in this first analysis the risks of treatment outweigh the benefits according to the decision of the safety committee the study could be stopped Also in the event that at this point there are statistically significant differences in favor of treatment by biliary sphincterotomy with respect to the primary outcome recruitment can be stopped and the study stopped early
In the group assigned to receive endoscopic treatment ERCP for biliary sphincterotomy will be performed during the index admission for acute pancreatitis prior to discharge or up till one month from discharge
The procedure will be performed after at least 6 hours of fasting during the index admission by endoscopists in charge of performing ERCP as usual in the collaborating centers under sedation controlled by endoscopists or anesthesia according to the usual practice of the Endoscopy Unit of each collaborating center
For ERCP biliary cannulation the usual techniques available in each center will be used including advanced cannulation techniques if necessary The type of papilla cannulation attempts time to biliary cannulation and the techniques used will be recorded Possible adverse effects will be recorded If biliary cannulation is not possible a new ERCP attempt will be performed within a maximum of one month If biliary cannulation is still not achieved it will be counted as a technical failure maintaining the established clinical follow-up
The inhospital management of patients with AP in the conservative treatment group before and after randomization will be under the care of their responsible physicians on the hospitalization wart at the corresponding collaboration center who will follow the management recommended by the clinical guidelines Their discharge will be decided by their regular physician
Periodic follow-up contacts will be made at one month at 6 months and at one year Contacts may be made by face-to-face or telematic visits after consultation with the patient especially if the patient is institutionalized or has severe mobility problems
In these contacts the following will be performed
Record of complications associated with the treatment received and record of BPE developed since the last visit especially the presence of biliary colic that did not require admission or evaluation in the emergency department An interview will be conducted aimed at collecting the presence of BPE that did not require admission such as biliary colic or related pain recording the type and date of onset The digital medical record will also be reviewed to record admissions and assessments by the emergency department related or unrelated to BPE and also to assess mortality
EORTQ30 quality of life questionnaire will be conducted in every visit
The primary aim is to assess the recurrence of the combined variable of biliopancreatic events BPE biliary colic cholangitis choledocholithiasis acute cholecystitis or AP of the endoscopic sphincterotomy strategy during the follow-up time after diagnosis of AP of biliary origin in inoperable patients with respect to conservative treatment
This is a randomized multicenter open-label nationwide intention-to-treat clinical trial Patients will be randomized 11 to the two treatment groups stratified by center and AP severity
Centers considered to participate as collaborators centers will need to have an endoscopy unit with ERCP availability that perform more than 150 ERCPsyear and endoscopists trained in this technique Patient inclusion and exclusion criteria is specified in a specific section of the protocol
For the inclusion of patients after diagnosis of biliary AP BAP and having ruled cholecystectomy as a possibility for the patient because of high surgical risk after evaluation by surgery or anesthesia or patients refusal to undergo cholecystectomy the absence of choledocholithiasis will be confirmed by MRCP or EUS
If the patient fulfills these requirements in addition to all the previous inclusion criteria and none of the exclusion criteria and agrees to participate in the study and signs the informed consent the patient will be included and randomized
This randomization will be carried out in each of the collaborating centers and the patient will be assigned to a treatment group following the random assignment method
The randomization of patients to each of the treatment groups will be carried out centrally by the REDCap software REDCap is a program that offers an online electronic data collection notebook It will be stratified by center and by severity of BAP mild moderate or severe according to the Revised Atlanta Classification
Patients will be randomized to receive ERCP biliary sphincterotomy or conservative management 63 patients will be allocated to each group An interim safety analysis is proposed which will be evaluated by an independent committee of 3 persons with experience in complications associated with ERCP and knowledge of biliopancreatic pathology once 50 of the sample reaches 6 months of follow-up In the event that in this first analysis the risks of treatment outweigh the benefits according to the decision of the safety committee the study could be stopped Also in the event that at this point there are statistically significant differences in favor of treatment by biliary sphincterotomy with respect to the primary outcome recruitment can be stopped and the study stopped early
In the group assigned to receive endoscopic treatment ERCP for biliary sphincterotomy will be performed during the index admission for acute pancreatitis prior to discharge or up till one month from discharge
The procedure will be performed after at least 6 hours of fasting during the index admission by endoscopists in charge of performing ERCP as usual in the collaborating centers under sedation controlled by endoscopists or anesthesia according to the usual practice of the Endoscopy Unit of each collaborating center
For ERCP biliary cannulation the usual techniques available in each center will be used including advanced cannulation techniques if necessary The type of papilla cannulation attempts time to biliary cannulation and the techniques used will be recorded Possible adverse effects will be recorded If biliary cannulation is not possible a new ERCP attempt will be performed within a maximum of one month If biliary cannulation is still not achieved it will be counted as a technical failure maintaining the established clinical follow-up
The inhospital management of patients with AP in the conservative treatment group before and after randomization will be under the care of their responsible physicians on the hospitalization wart at the corresponding collaboration center who will follow the management recommended by the clinical guidelines Their discharge will be decided by their regular physician
Periodic follow-up contacts will be made at one month at 6 months and at one year Contacts may be made by face-to-face or telematic visits after consultation with the patient especially if the patient is institutionalized or has severe mobility problems
In these contacts the following will be performed
Record of complications associated with the treatment received and record of BPE developed since the last visit especially the presence of biliary colic that did not require admission or evaluation in the emergency department An interview will be conducted aimed at collecting the presence of BPE that did not require admission such as biliary colic or related pain recording the type and date of onset The digital medical record will also be reviewed to record admissions and assessments by the emergency department related or unrelated to BPE and also to assess mortality
EORTQ30 quality of life questionnaire will be conducted in every visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None