Ignite Creation Date:
2024-05-06 @ 2:57 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04479228
Status:
UNKNOWN
Last Update Posted:
2020-07-21
First Post:
2020-07-15
Brief Title:
Plastic Stents vs NAGI Bi-flanged Metal Stent for Endoscopic Ultrasound Guided Drainage of Walled-off Necrosis
Sponsor:
Asian Institute of Gastroenterology India
Organization:
Asian Institute of Gastroenterology India
Study Overview
Official Title:
A Randomized Control Trial of Plastic Stents vs NAGI Bi-flanged Metal Stent for Endoscopic Ultrasound Guided Drainage of Walled-off Necrosis
Status:
UNKNOWN
Status Verified Date:
2020-07
Last Known Status:
NOT_YET_RECRUITING
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:
Introduction
Walled off necrosis WON is defined as a well circumscribed pancreatic andor peri pancreatic necrosis containing a variable amount of necrotic tissue WON usually occurs 4 weeks after onset of necrotizing pancreatitis It is associated with significant morbidity and mortality especially if infected Symptomatic WON should be drained either percutaneously endoscopically or surgically Minimal invasive approaches are being increasingly used for effective management of WON as it is associated with less adverse events Various recent studies have shown that endoscopic approach have improved clinical outcome less hospital stay and lower cost compared to surgical approach
Endoscopic ultrasound guided drainage of WON with either plastic stents or lumen apposing metal stents LAMS is mainstay of WON management A systemic review based on retrospective comparative studies showed no difference regarding treatment success for WON by plastic or metal stents6 However metal stent had shorter procedure time A Single center RCT from USA comparing LAMS vs multiple plastic stents for WON has shown that except shorter procedure duration there was no significant difference in treatment outcomes To minimize LAMS related adverse events it should be removed within 3 weeks However in the same study 258 patients of LAMS group and 552 patients of plastic stent group underwent additional intervention within 72 hours for persistent symptoms
Larger diameter specific stent designs to reduce adverse events should have better outcome with LAMS as compared to plastic stents Primary outcome of this single center randomized controlled trial is to examine whether dedicated NAGI bi-flanged metal stents BFMS are superior to plastic stent in terms of short term and long term success
Aims and Hypothesis
The aim of the current study is to study whether NAGI BFMS are superior to plastic stent in terms of short term and long term success in the EUS guided drainage of WON
The investigators hypothesize that the clinical success with NAGI BFMS would be better than plastic stents in the EUS guided drainage of WON
Walled off necrosis WON is defined as a well circumscribed pancreatic andor peri pancreatic necrosis containing a variable amount of necrotic tissue WON usually occurs 4 weeks after onset of necrotizing pancreatitis It is associated with significant morbidity and mortality especially if infected Symptomatic WON should be drained either percutaneously endoscopically or surgically Minimal invasive approaches are being increasingly used for effective management of WON as it is associated with less adverse events Various recent studies have shown that endoscopic approach have improved clinical outcome less hospital stay and lower cost compared to surgical approach
Endoscopic ultrasound guided drainage of WON with either plastic stents or lumen apposing metal stents LAMS is mainstay of WON management A systemic review based on retrospective comparative studies showed no difference regarding treatment success for WON by plastic or metal stents6 However metal stent had shorter procedure time A Single center RCT from USA comparing LAMS vs multiple plastic stents for WON has shown that except shorter procedure duration there was no significant difference in treatment outcomes To minimize LAMS related adverse events it should be removed within 3 weeks However in the same study 258 patients of LAMS group and 552 patients of plastic stent group underwent additional intervention within 72 hours for persistent symptoms
Larger diameter specific stent designs to reduce adverse events should have better outcome with LAMS as compared to plastic stents Primary outcome of this single center randomized controlled trial is to examine whether dedicated NAGI bi-flanged metal stents BFMS are superior to plastic stent in terms of short term and long term success
Aims and Hypothesis
The aim of the current study is to study whether NAGI BFMS are superior to plastic stent in terms of short term and long term success in the EUS guided drainage of WON
The investigators hypothesize that the clinical success with NAGI BFMS would be better than plastic stents in the EUS guided drainage of WON
Detailed Description:
11 Patient recruitment Patients would be recruited from the in-patient or outpatient department prior to their scheduled endoscopic intervention
12 Study design This is a single center randomized controlled study with two parallel groups without masking with a 11 allocation ratio
13 Study intervention - stent placement The procedures would be performed by experienced endoscopists All procedures will be performed with the patient in the left lateral position under propofol sedation after administration of intravenous antibiotics third generation cephalosporins A therapeutic linear echo-endoscope UCT-180 Olympus Ltd Tokyo Japan will be used the PFC assessed for size wall maturity thickness interposing collaterals and percentage of solid debris
NAGI BFMS - The WON will be punctured using a standard 19-gauge FNA needle and the aspirate was sent for biochemical and microbial analysis A 0025-inch Visiglide Olympus Corporation Tokyo Japan or 0035-inch stiff guidewire Jag Wire Boston Scientific passed through the needle into the cyst cavity to form at least 1 to 2 loops under fluoroscopic guidance A 6F cystotome Endo-flex GmbH Dusseldorf Germany will be passed over the guidewire for creating a fistula Subsequently a 6-mm balloon dilator Hurricane Boston Scientific Corporation or Titan balloon Wilson Cook will be used to further dilate the fistula tract After this the stent delivery catheter is advanced over the guidewire across the PFC wall and the BFMS Nagi Taewoong Medical Gyeonggi-do South Korea deployed using sonographic fluoroscopic and endoscopic visualization
Plastic stents - Double-pigtail plastic stents will be used A minimum of one 10Fr pigtail plastic stent will be placed After initial EUS-guided access the ostomy will be dilated first using a cystotome and secondly with a balloon dilation The plastic stent will be inserted and delivered following the routine technique of each interventional endoscopist The number of the plastic stents and the size of the balloon used to dilate the ostomy will depend on the WON size and content
14 Stents NAGI bi-flanged metal stent BFMS- Nagi stent is a dedicated self-expandable fully covered bi-flanged metal stent BFMS for drainage of pancreatic fluid collections The stent is short in length 20 or 30 mm with caliber 10 12 14 or16 mm having flared ends diameter 26 mm Procedure-related adverse events will be managed accordingly and documented Plastic stents - Two 7fr or 10 fr plastic stents will be used 15 Randomization The patients would be randomised will be randomised to Plastic vs NAGI BFMS by using Med Cal C software version 123 Belgium There will be no masking
16 Post-procedural management After the drainage procedure patients will be observed in the hospital for symptomatic improvement or development of any adverse events Oral liquids are allowed 6 hours after the procedure Intravenous antibiotics will be continued for 2 to 3 days which will be later changed to the oral route
All patients will be re-assessed within 72 hours after EUS guided drainage for symptomatic relief In case of persistent symptoms the most beneficial therapeutic approach for the patient will be adopted as per expert multimodality team of endoscopists surgeon and interventional radiologist such as placement of nasocystic drain coaxial plastic stent placement in BFMS endoscopic necrosectomy or percutaneous drainage
In case of symptomatic relief and significant reduction in size of WON patient will be followed up after 1 week and at 4 week or early if symptoms recur andor any new symptom appears In case of complete symptomatic relief and disappearance of WON at 4 weeks metal stent will be removed
If persistent collection or there is evidence of DPDS then in patients with initial plastic stent placement stent will not be removed In BFMS group BFMS will be replaced by plastic stent Patient will be observed in hospital for 24 hours 17 Outcome measurements The primary outcome measurement is Clinical success at 4 weeks determined by the reduction of the collection 50 or 5 cm in size along with resolution of symptoms Secondary outcomes include
1 Re-interventions
2 Long term clinical success at 24 weeks
3 Adverse events
4 Cost - effectiveness
Technical success It is defined as the correct deployment of stent at both ends with visualization of drainage of the liquid
Clinical success It is defined as resolution of symptoms and significant reduction in of collection size 50 or 5 cm in size
Recurrence It is appearance of symptomatic fluid collection evident on imaging during follow-up after documented clinical success
Adverse events It is defined as undesirable situations during the study period whether related or unrelated to the EUS guided drainage
18 Follow-up Patient will be assessed on day 1 to 3 then at 1 4 8 weeks followed by 12 and 24 weeks by personnel participating in the study At each visit information regarding signs and symptoms adverse events and recurrence will be collected In case of mortality during study period any possible relation to endoscopic procedure will be investigated and will be noted
19 Sample size calculation The success rate of metal stent is assumed as 75 and 45 for plastic stent The required sample size with 80 power and 005 as type 1 error is 40 per group
Statistical Formula for estimation of sample size
n 2 Zα Zβ2 P1Q1P2Q2 P1 -P2 XP1-P2
where n Sample size
P1 proportion of outcome measure under Group1 Success rate of metal stent and assumed to be 75 Q1 proportion of failure rate metal stent 1 - 085 P2 proportion of success rate in plastic group2 success rate and assumed as 45 Q2 proportion failure rate of plastic stent in group 2 1 - 045 zα is factor corresponding to type 1 error with two sided test and is taken as 196 Zβ factor corresponding to type 11 error ie 1- β is power of and is usually taken as 80 and the value 084 Forty patients will be recruited in each group to reject the null hypothesis that the proportion of clinical success in the LAMS group is equal to that of the plastic stent group with an 80 power with 5 type 1 error A planned interim analysis will be done at half of the recruitment
110 Statistical analyses The continuous variables will be described as mean standard deviation median range and interquartile range Categorical variables will be described as percentages of different categories
Primary outcome will be tested with chi-square test or Fishers exact test The level of significance has been set at 5 To quantify the magnitude of the difference the relative risk and odds ratio will be calculated with 95 confidence interval Univariate and multivariate analysis will be done to determine which are the factors associated with clinical success and clinical recurrence Kaplan-Meier survival analysis will be done for appearance clinical recurrence
111 Withdrawal of individual subjects Subjects can leave the study at any time for any reason if they wish to do so without any consequences The treating physician can decide to withdraw a subject from the study for any medical reason In case of withdrawal the reason for withdrawal and if applicable the alternative treatment would be recorded
112 Participating centres Asian Institute of Gastroenterology - Hyderabad
12 Study design This is a single center randomized controlled study with two parallel groups without masking with a 11 allocation ratio
13 Study intervention - stent placement The procedures would be performed by experienced endoscopists All procedures will be performed with the patient in the left lateral position under propofol sedation after administration of intravenous antibiotics third generation cephalosporins A therapeutic linear echo-endoscope UCT-180 Olympus Ltd Tokyo Japan will be used the PFC assessed for size wall maturity thickness interposing collaterals and percentage of solid debris
NAGI BFMS - The WON will be punctured using a standard 19-gauge FNA needle and the aspirate was sent for biochemical and microbial analysis A 0025-inch Visiglide Olympus Corporation Tokyo Japan or 0035-inch stiff guidewire Jag Wire Boston Scientific passed through the needle into the cyst cavity to form at least 1 to 2 loops under fluoroscopic guidance A 6F cystotome Endo-flex GmbH Dusseldorf Germany will be passed over the guidewire for creating a fistula Subsequently a 6-mm balloon dilator Hurricane Boston Scientific Corporation or Titan balloon Wilson Cook will be used to further dilate the fistula tract After this the stent delivery catheter is advanced over the guidewire across the PFC wall and the BFMS Nagi Taewoong Medical Gyeonggi-do South Korea deployed using sonographic fluoroscopic and endoscopic visualization
Plastic stents - Double-pigtail plastic stents will be used A minimum of one 10Fr pigtail plastic stent will be placed After initial EUS-guided access the ostomy will be dilated first using a cystotome and secondly with a balloon dilation The plastic stent will be inserted and delivered following the routine technique of each interventional endoscopist The number of the plastic stents and the size of the balloon used to dilate the ostomy will depend on the WON size and content
14 Stents NAGI bi-flanged metal stent BFMS- Nagi stent is a dedicated self-expandable fully covered bi-flanged metal stent BFMS for drainage of pancreatic fluid collections The stent is short in length 20 or 30 mm with caliber 10 12 14 or16 mm having flared ends diameter 26 mm Procedure-related adverse events will be managed accordingly and documented Plastic stents - Two 7fr or 10 fr plastic stents will be used 15 Randomization The patients would be randomised will be randomised to Plastic vs NAGI BFMS by using Med Cal C software version 123 Belgium There will be no masking
16 Post-procedural management After the drainage procedure patients will be observed in the hospital for symptomatic improvement or development of any adverse events Oral liquids are allowed 6 hours after the procedure Intravenous antibiotics will be continued for 2 to 3 days which will be later changed to the oral route
All patients will be re-assessed within 72 hours after EUS guided drainage for symptomatic relief In case of persistent symptoms the most beneficial therapeutic approach for the patient will be adopted as per expert multimodality team of endoscopists surgeon and interventional radiologist such as placement of nasocystic drain coaxial plastic stent placement in BFMS endoscopic necrosectomy or percutaneous drainage
In case of symptomatic relief and significant reduction in size of WON patient will be followed up after 1 week and at 4 week or early if symptoms recur andor any new symptom appears In case of complete symptomatic relief and disappearance of WON at 4 weeks metal stent will be removed
If persistent collection or there is evidence of DPDS then in patients with initial plastic stent placement stent will not be removed In BFMS group BFMS will be replaced by plastic stent Patient will be observed in hospital for 24 hours 17 Outcome measurements The primary outcome measurement is Clinical success at 4 weeks determined by the reduction of the collection 50 or 5 cm in size along with resolution of symptoms Secondary outcomes include
1 Re-interventions
2 Long term clinical success at 24 weeks
3 Adverse events
4 Cost - effectiveness
Technical success It is defined as the correct deployment of stent at both ends with visualization of drainage of the liquid
Clinical success It is defined as resolution of symptoms and significant reduction in of collection size 50 or 5 cm in size
Recurrence It is appearance of symptomatic fluid collection evident on imaging during follow-up after documented clinical success
Adverse events It is defined as undesirable situations during the study period whether related or unrelated to the EUS guided drainage
18 Follow-up Patient will be assessed on day 1 to 3 then at 1 4 8 weeks followed by 12 and 24 weeks by personnel participating in the study At each visit information regarding signs and symptoms adverse events and recurrence will be collected In case of mortality during study period any possible relation to endoscopic procedure will be investigated and will be noted
19 Sample size calculation The success rate of metal stent is assumed as 75 and 45 for plastic stent The required sample size with 80 power and 005 as type 1 error is 40 per group
Statistical Formula for estimation of sample size
n 2 Zα Zβ2 P1Q1P2Q2 P1 -P2 XP1-P2
where n Sample size
P1 proportion of outcome measure under Group1 Success rate of metal stent and assumed to be 75 Q1 proportion of failure rate metal stent 1 - 085 P2 proportion of success rate in plastic group2 success rate and assumed as 45 Q2 proportion failure rate of plastic stent in group 2 1 - 045 zα is factor corresponding to type 1 error with two sided test and is taken as 196 Zβ factor corresponding to type 11 error ie 1- β is power of and is usually taken as 80 and the value 084 Forty patients will be recruited in each group to reject the null hypothesis that the proportion of clinical success in the LAMS group is equal to that of the plastic stent group with an 80 power with 5 type 1 error A planned interim analysis will be done at half of the recruitment
110 Statistical analyses The continuous variables will be described as mean standard deviation median range and interquartile range Categorical variables will be described as percentages of different categories
Primary outcome will be tested with chi-square test or Fishers exact test The level of significance has been set at 5 To quantify the magnitude of the difference the relative risk and odds ratio will be calculated with 95 confidence interval Univariate and multivariate analysis will be done to determine which are the factors associated with clinical success and clinical recurrence Kaplan-Meier survival analysis will be done for appearance clinical recurrence
111 Withdrawal of individual subjects Subjects can leave the study at any time for any reason if they wish to do so without any consequences The treating physician can decide to withdraw a subject from the study for any medical reason In case of withdrawal the reason for withdrawal and if applicable the alternative treatment would be recorded
112 Participating centres Asian Institute of Gastroenterology - Hyderabad
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