Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620328
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Safety and Efficacy of Mechanical Versus Electrocautery Dilator for EUS-guided Biliary Drainage MED-BD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety and Efficacy of Mechanical Versus Electrocautery Dilator for EUS-guided Biliary Drainage A Prospective Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
MED-BD
Brief Summary:
The purpose of this study is to investigate the likelihood of post-dilation bleeding using mechanical or electrocautery dilation We hypothesized that the risk of bleeding is lower in the mechanical group
Detailed Description:
1 Study background In recent years with the advancement of endoscopy endoscopic ultrasound-guided biliary drainage EUS-BD has been increasingly applied in cases of failed endoscopic retrograde cholangiopancreatographyERCP According to the European Society of Gastrointestinal Endoscopy guidelines1 in patients with malignant obstruction of the distal bile duct if ERCP drainage fails EUS-guided biliary drainage is superior to percutaneous transhepatic biliary drainage PTBD In patients with malignant obstruction of the proximal bile duct combined with left-sided bile duct dilatation EUS-guided biliary drainage can also be considered
The direct transmural technique is the most common method for EUS-guided biliary drainage23 Under endoscopic ultrasound guidance the dilated bile duct is observed from the stomach or duodenum A fine needle is then used for duct puncture and a guidewire is advanced into the duct followed by tract dilation to create an artificial fistula Finally a plastic or metal stent is placed to achieve drainage Common complications of EUS-guided drainage procedures include bleeding intestinal perforation bile leakage and stent migration with tract dilation being the most common step leading to complications45 The two main methods of tract dilation are electrocautery dilation and mechanical dilation Currently there are only retrospective studies comparing the success rates complications and short- and long-term outcomes between these two methods6 However no any randomized controlled trial has investigated the safety and efficacy of the two traction dilation method on EUS-BD Therefore this study will attempt to clarify the differences in bleeding other complications success rates of dilation and drainage success rates between these two dilation methods through randomized allocation
2 Study Design Multi-center randomized clinical trial included National Taiwan University Hospital Hsin-Chu branch National Cheng Kung University Hospital Chang Gung Memorial Hospital Taichung Veterans General Hospital Taipei Tzu Chi Hospital Shin Kong Wu Ho Su Memorial Hospital Far Eastern Memorial Hospital China Medical University Hospital Chung Shan Medical University Hospital and Taitung Mackay Memorial Hospital will enroll 64 patients and the study period is 12 months
Randomization will be done by opening sealed opaque envelopes containing computer generated random sequences in blocks of 4
Patients will be randomly assigned to electrocautery dilation arm vs mechanical dilation arm on 11 basis
3 Subjects Consecutive patients aged more than 18 years old indicated for EUS-guided biliary drainage were included
Inclusion criteria 1 Failed ERCP 2 The papilla is inaccessible owing to a surgically altered anatomy or gastric outlet obstruction 3 Contraindications for PTCD such as ascites and possibility of self-tube removal Exclusion criteria 1 Patients younger than 18 years old 2 Cancer infiltration of the gastricduodenal wall within the planned puncture route 3 Patients with uncorrectable coagulopathy 4 Patients with unmanageable ascites 5 Patients with serious comorbidities that prohibited endoscopic management 6 Patients with pregnancy 7 Patients who cannot or refuse to provide informed consent
4 Study intervention Skilled endosonographers performed EUS-BD with patients under conscious sedation by intravenous medication All patients were given intravenous antibiotics prophylactically A therapeutic curved linear array echoendoscope is positioned in the stomach with carbon dioxide insufflation Standard 19G fine needles are used to puncture the dilated left intrahepatic bile duct or commo bile duct Bile juice aspiration with 20ml syringe was performed to confirm intraductal puncture After contrast medium injection an insulated guidewire 0025 inch VisiGlide2 Olympus Medical Systems Tokyo Japan is advanced antegradely
Dilation of the needle tract is initially performed with a diathermic sheath 6Fr Cyst-Gastro set Endoflex Voerde Germany or an ultra-tapered mechanical dilator 7Fr ES Dilator Zeon Medical Co Tokyo Japan according to randomization result If needed additional dilation can be attempted with dilating balloon Finally the dedicated plastic stent or partially covered self-expandable metallic stents PCSEMS is transmurally placed
5 Measure outcomes
Primary outcome
- Bleeding hematemesis andor melena or hemoglobin drop over 2gdL needed blood transfusion endoscopic hemostasis radiological intervention or surgery
Secondary outcomes
Tract dilation success tract dilation was regarded as successful when the maximum diameter portion of the first dilator into the bile duct
Final procedure success a successful deployment of a stent in the intended location
Procedural duration the time elapsed between puncture of the intrahepatic duct and completion of deployment of stent
Clinical success a decrease in bilirubin within 30 days to lt 75 of levels before EUS-BD
Recurrent biliary obstruction RBO cholangitis and jaundice accompanied by biliary dilation on imaging examinations
Time to RBO TRBO the time from EUS-BD to the date of RBO occurrence
Adverse events other than bleeding pancreatitis cholangitis peritonitis and perforation in accordance with the American Society for GI Endoscopy lexicon7
Length of hospital stay after procedure
Overall survival
The direct transmural technique is the most common method for EUS-guided biliary drainage23 Under endoscopic ultrasound guidance the dilated bile duct is observed from the stomach or duodenum A fine needle is then used for duct puncture and a guidewire is advanced into the duct followed by tract dilation to create an artificial fistula Finally a plastic or metal stent is placed to achieve drainage Common complications of EUS-guided drainage procedures include bleeding intestinal perforation bile leakage and stent migration with tract dilation being the most common step leading to complications45 The two main methods of tract dilation are electrocautery dilation and mechanical dilation Currently there are only retrospective studies comparing the success rates complications and short- and long-term outcomes between these two methods6 However no any randomized controlled trial has investigated the safety and efficacy of the two traction dilation method on EUS-BD Therefore this study will attempt to clarify the differences in bleeding other complications success rates of dilation and drainage success rates between these two dilation methods through randomized allocation
2 Study Design Multi-center randomized clinical trial included National Taiwan University Hospital Hsin-Chu branch National Cheng Kung University Hospital Chang Gung Memorial Hospital Taichung Veterans General Hospital Taipei Tzu Chi Hospital Shin Kong Wu Ho Su Memorial Hospital Far Eastern Memorial Hospital China Medical University Hospital Chung Shan Medical University Hospital and Taitung Mackay Memorial Hospital will enroll 64 patients and the study period is 12 months
Randomization will be done by opening sealed opaque envelopes containing computer generated random sequences in blocks of 4
Patients will be randomly assigned to electrocautery dilation arm vs mechanical dilation arm on 11 basis
3 Subjects Consecutive patients aged more than 18 years old indicated for EUS-guided biliary drainage were included
Inclusion criteria 1 Failed ERCP 2 The papilla is inaccessible owing to a surgically altered anatomy or gastric outlet obstruction 3 Contraindications for PTCD such as ascites and possibility of self-tube removal Exclusion criteria 1 Patients younger than 18 years old 2 Cancer infiltration of the gastricduodenal wall within the planned puncture route 3 Patients with uncorrectable coagulopathy 4 Patients with unmanageable ascites 5 Patients with serious comorbidities that prohibited endoscopic management 6 Patients with pregnancy 7 Patients who cannot or refuse to provide informed consent
4 Study intervention Skilled endosonographers performed EUS-BD with patients under conscious sedation by intravenous medication All patients were given intravenous antibiotics prophylactically A therapeutic curved linear array echoendoscope is positioned in the stomach with carbon dioxide insufflation Standard 19G fine needles are used to puncture the dilated left intrahepatic bile duct or commo bile duct Bile juice aspiration with 20ml syringe was performed to confirm intraductal puncture After contrast medium injection an insulated guidewire 0025 inch VisiGlide2 Olympus Medical Systems Tokyo Japan is advanced antegradely
Dilation of the needle tract is initially performed with a diathermic sheath 6Fr Cyst-Gastro set Endoflex Voerde Germany or an ultra-tapered mechanical dilator 7Fr ES Dilator Zeon Medical Co Tokyo Japan according to randomization result If needed additional dilation can be attempted with dilating balloon Finally the dedicated plastic stent or partially covered self-expandable metallic stents PCSEMS is transmurally placed
5 Measure outcomes
Primary outcome
- Bleeding hematemesis andor melena or hemoglobin drop over 2gdL needed blood transfusion endoscopic hemostasis radiological intervention or surgery
Secondary outcomes
Tract dilation success tract dilation was regarded as successful when the maximum diameter portion of the first dilator into the bile duct
Final procedure success a successful deployment of a stent in the intended location
Procedural duration the time elapsed between puncture of the intrahepatic duct and completion of deployment of stent
Clinical success a decrease in bilirubin within 30 days to lt 75 of levels before EUS-BD
Recurrent biliary obstruction RBO cholangitis and jaundice accompanied by biliary dilation on imaging examinations
Time to RBO TRBO the time from EUS-BD to the date of RBO occurrence
Adverse events other than bleeding pancreatitis cholangitis peritonitis and perforation in accordance with the American Society for GI Endoscopy lexicon7
Length of hospital stay after procedure
Overall survival
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