Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133835
Status:
COMPLETED
Last Update Posted:
2022-03-09
First Post:
2005-08-22
Brief Title:
Comparison of ESWL Alone and ESWL Endoscopy for Painful Chronic Pancreatitis
Sponsor:
Erasme University Hospital
Organization:
Erasme University Hospital
Study Overview
Official Title:
Comparison of ESWL Alone and ESWL Combined With Endoscopic Drainage of the Main Pancreatic Duct for Painful Chronic Pancreatitis
Status:
COMPLETED
Status Verified Date:
2005-07
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:
None
Brief Summary:
Endoscopy is an established method of treatment for painful obstructive calcified pancreatitis It involves the disintegration of calcifications using extracorporeal shock wave lithotripsy ESWL followed by endoscopic removal of stone fragments possibly associated with stent insertion A pilot study suggests that ESWL alone relieves pain in calcified chronic pancreatitis CP The aim of this study is to compare both techniques in a randomized controlled trial
Detailed Description:
Endoscopic drainage of the main pancreatic duct is an established method of treatment of painful obstructive calcified chronic pancreatitis CP It involves disintegration of calcifications using extracorporeal shock wave lithotripsy ESWL followed by endoscopic removal of stone fragments possibly associated with stent insertion A pilot study suggests that ESWL alone in calcified CP is followed by spontaneous elimination of stone fragments and pain relief without sphincterotomy After ESWL alone the exocrine function was found to return to normal values in some cases Potential benefits include lower costs and morbidity as well as wider availability compared to endoscopic techniques
The primary outcome of this randomized controlled trial is to compare the relapse of pain at 2 years after treatment with ESWL alone or endoscopic treatment consisting of ESWL followed by endoscopic stone extraction Secondary outcomes include a comparison of technical results as assessed by abdominal CT Scan 1 week after the last intervention and secretin-enhanced magnetic resonance at 1 month complication rates and treatment-related costs in both groups
Patients are eligible to participate in the study according to the following criteria
Inclusion criteria
painful chronic pancreatitis abdominal pain attack during the preceding 12 months
at least 1 calcified stone greater than 4 mm in one of its axes in the cephalic or corporeal portion of the main pancreatic duct with upstream duct dilation
written informed consent obtained from the patient
Exclusion criteria
history of treatment of the pancreas using ESWL endoscopy or surgery
pancreatic collection greater than 2 cm in diameter at magnetic resonance or CT Scan
alkaline phosphatase levels greater than twice the upper limit of normal values or signs of cholangitis
age below 18 years
pregnancy or lactation
Pretherapeutic work-up will include detailed medical history including date of the first episode of typical abdominal pain date of diagnosis of CP number of episodes of pain during the last year alcohol intake pain continuous or intermittent during the last episode medication intensity of the last episode of pain on a 10-point scale as previously described blood chemistry stool sampling for elastase measurement triolein breath test plain abdominal film taken in four classical positions left anterior oblique right anterior oblique lateral and supine CT Scan without contrast medium injection and secretin-enhanced magnetic resonance cholangiopancreatography S-MRCP
After informed consent of the referring physician has been obtained patients will be asked to participate in the study If the patient accepts after oral and written consent he or she will be randomized to the ESWL or endoscopy group by opening an opaque sealed envelope numbered according to a table of random numbers
ESWL will be performed in all patients using a electromagnetic lithotriptor as previously described Shock-waves will be focused on the obstructing stones if multiple stones are present those responsible for MPD obstruction will be identified by comparing plain abdominal film CT Scan and S-MRCP ESWL sessions will be repeated if necessary until stone fragmentation is obtained as confirmed by abdominal plain film centered on the targeted area of the pancreas At this time treatment will be considered terminated in the ESWL group patients in the endoscopy group will undergo endoscopy immediately for endoscopic extraction of stone fragments possibly associated to stent insertion according to previously published criteria and techniques
Cross-over in the ESWL group if no elimination of the fragments is observed one week after the last ESWL endoscopic drainage of the main pancreatic duct will be carried out at this time in case of continuous pain For patients without continuous pain delayed spontaneous elimination of the fragments will be sought by CT Scan and S-MRCP 2 months after the last ESWL Endoscopic drainage of the main pancreatic duct will be proposed during follow-up only to the patients presenting a painful attack of CP
Follow-up will consist of clinical examination 1 month after treatment and every 6 months thereafter Data collected will include pain relapses ESWL endoscopic and surgical procedures weight change plus any other seemingly unrelated medical treatments In addition to this a S-MRCP will be performed 1 month after treatment Triolein breath test will be performed at 1 month and 1 year Sampling of stools for elastase measurement will be obtained every year
Costs will be calculated starting on the day of first treatment as previously described Costs not directly related to the treatment of pain or of procedure-related complications eg diabetes will be disregarded
The primary outcome of this randomized controlled trial is to compare the relapse of pain at 2 years after treatment with ESWL alone or endoscopic treatment consisting of ESWL followed by endoscopic stone extraction Secondary outcomes include a comparison of technical results as assessed by abdominal CT Scan 1 week after the last intervention and secretin-enhanced magnetic resonance at 1 month complication rates and treatment-related costs in both groups
Patients are eligible to participate in the study according to the following criteria
Inclusion criteria
painful chronic pancreatitis abdominal pain attack during the preceding 12 months
at least 1 calcified stone greater than 4 mm in one of its axes in the cephalic or corporeal portion of the main pancreatic duct with upstream duct dilation
written informed consent obtained from the patient
Exclusion criteria
history of treatment of the pancreas using ESWL endoscopy or surgery
pancreatic collection greater than 2 cm in diameter at magnetic resonance or CT Scan
alkaline phosphatase levels greater than twice the upper limit of normal values or signs of cholangitis
age below 18 years
pregnancy or lactation
Pretherapeutic work-up will include detailed medical history including date of the first episode of typical abdominal pain date of diagnosis of CP number of episodes of pain during the last year alcohol intake pain continuous or intermittent during the last episode medication intensity of the last episode of pain on a 10-point scale as previously described blood chemistry stool sampling for elastase measurement triolein breath test plain abdominal film taken in four classical positions left anterior oblique right anterior oblique lateral and supine CT Scan without contrast medium injection and secretin-enhanced magnetic resonance cholangiopancreatography S-MRCP
After informed consent of the referring physician has been obtained patients will be asked to participate in the study If the patient accepts after oral and written consent he or she will be randomized to the ESWL or endoscopy group by opening an opaque sealed envelope numbered according to a table of random numbers
ESWL will be performed in all patients using a electromagnetic lithotriptor as previously described Shock-waves will be focused on the obstructing stones if multiple stones are present those responsible for MPD obstruction will be identified by comparing plain abdominal film CT Scan and S-MRCP ESWL sessions will be repeated if necessary until stone fragmentation is obtained as confirmed by abdominal plain film centered on the targeted area of the pancreas At this time treatment will be considered terminated in the ESWL group patients in the endoscopy group will undergo endoscopy immediately for endoscopic extraction of stone fragments possibly associated to stent insertion according to previously published criteria and techniques
Cross-over in the ESWL group if no elimination of the fragments is observed one week after the last ESWL endoscopic drainage of the main pancreatic duct will be carried out at this time in case of continuous pain For patients without continuous pain delayed spontaneous elimination of the fragments will be sought by CT Scan and S-MRCP 2 months after the last ESWL Endoscopic drainage of the main pancreatic duct will be proposed during follow-up only to the patients presenting a painful attack of CP
Follow-up will consist of clinical examination 1 month after treatment and every 6 months thereafter Data collected will include pain relapses ESWL endoscopic and surgical procedures weight change plus any other seemingly unrelated medical treatments In addition to this a S-MRCP will be performed 1 month after treatment Triolein breath test will be performed at 1 month and 1 year Sampling of stools for elastase measurement will be obtained every year
Costs will be calculated starting on the day of first treatment as previously described Costs not directly related to the treatment of pain or of procedure-related complications eg diabetes will be disregarded
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