EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent
Primary Purpose
Pancreatic Pseudocyst, Pancreatic Necrosis, Biliary Obstruction
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
EUS-guided drainage
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Pseudocyst
Eligibility Criteria
Inclusion Criteria:
Patient must meet all of the following inclusion criteria to be eligible for enrollment into the study.
- Pancreatobiliary diseases that are eligible for EUS-guided transenteric drainage
- The patient who aged from 20 to 80 years. Legally acceptable representative must be capable of giving written informed consent prior to participation in this study
- Target lesion that is accessible through the transenteric approach
- The woman of child-bearing age must be negative from the pregnancy test in order to participate in this study
- The patient who is willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures
- The patients should not have any unacceptable conditions (e.g., physiological, familyism, social, geographical) for medical follow-up and adaptation of the study.
Exclusion Criteria:
Patient presenting with any of the following will not be included in the study.
- Inaccessible to EUS-guided approach
- Bleeding tendency: International normalized ratio (INR) of prothrombin time < 1.5 or platelet conunt < 60,000/mm3
- Patients with Disseminated Intravascular Coagulation syndrome(DIC)
- Patients who have been taking medicines that can cause hemorrhage (e.g., Aspirin, Wafarin etc.)
- Patients with other serious disease or medical condition
- Patients with past medical history of significant neurologic or Psychiatric disorders such as dementia or seizure
- Unstable heart disease despite of treatment, recent myocardial infarction within 6 month (Even though MI was diagnosed within 6 months, if it becomes stable presently, the patient can be possible to participate).
Sites / Locations
- Chinese University of Hong Kong
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EUS guided drainage
Arm Description
Patients suffering from the conditions in focus would receive EUS guided drainage with the lumen apposing stent
Outcomes
Primary Outcome Measures
Clinical success for pancreatic fluid collections
① Clinical success of pancreatic fluid collections
Peudocyst: resolution more than 50% in the initial size of cyst.
Walled-off necrosis: resolution of PFC without the need for additional interventions after endoscopic interventions.
Clinical success for acute cholecystitis
- Afebrile for 8 hours, tolerating diet, absence of abdominal sign, or 20% decrease in white cell count.
Clinical success for obstructive jaundice
- A decrease in total bilirubin to < 50 % of the pre-stenting value within 2 weeks.
Secondary Outcome Measures
Techincal success
- Satisfactory access, placement of stent and drainage.
Adverse events
Bleeding: any hemorrhagic event during or after the procedure that required endotherapy, radiological interventions, blood product transfusion, or inpatient observation.
Perforation: perforation of the GI tract or cystic wall on imaging studies with peritonitis signs.
Pneumoperitoneum or pneumoretroperitoneum: intraperitoneal or retroperitoneal air on imaging study.
Stent migration: dislocation of the stent into the lumen or the GI tract on imaging study
Full Information
NCT ID
NCT03002051
First Posted
December 16, 2016
Last Updated
December 12, 2019
Sponsor
Chinese University of Hong Kong
Collaborators
SoonChunHyang University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03002051
Brief Title
EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent
Official Title
EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent for the Management of Pancreato-biliary Diseases: a Multi-national, Multicenter Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
May 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
SoonChunHyang University School of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate clinical efficacy and safety of a novel lumen-apposing FCSEMS for EUS-guided transenteric drainage of PFC or of biliary tree including GB
Detailed Description
Patients with the following conditions would be recruited for drainage under EUS guidance with the new lumen apposing FCSEMS
Symptomatic or infected pancreatic pseudocyst or walled-off necrosis (WON) (SPAXUS 16 or 10 mm)
Acute cholecystitis by inoperable malignant diseases (SPAXUS 10 mm)
Acute cholecystitis by benign conditions with high-risk for operation (SPAXUS 10 mm)
Long-term cholecystostomy at high-risk for operation (SPAXUS 10 mm)
Symptomatic malignant obstruction of the distal CBD with unsuccessful transpapillary approach (the diameter of the CBD > 10 mm) (SPAXUS 8 or 10 mm)
Outcome paramaters include technical and clinical success, adverse events.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Pseudocyst, Pancreatic Necrosis, Biliary Obstruction, Acute Cholecystitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EUS guided drainage
Arm Type
Experimental
Arm Description
Patients suffering from the conditions in focus would receive EUS guided drainage with the lumen apposing stent
Intervention Type
Device
Intervention Name(s)
EUS-guided drainage
Intervention Description
Ultrasonographic evaluation of the lesion by linear echoendoscope and positioning for transenteric puncture in shortest distance between enteric wall and the target lumen for drainage.
EUS-guided transenteric puncture by using a 19-gauge needle followed by placement of a 0.035 or 0.025-inch guidewire into the target lumen.
After the needle is removed in remaining the guidewire, the tract is dilated over the guidewire by using bougie dilator or needle type cystotome (Endoflex, Voerde, Germany). And then, the tract may be more dilated by using balloon catheter (4-mm).
After dilation of the tract, stent delivery system is inserted over the guidewire into the target lumen.
After complete deployment of the distal flange under EUS and fluoroscopic guidance into the target lumen, proximal retraction of the delivery system until the blue mark on the handle of the introducer is seen. And then, the proximal flange is deployed slowly under endoscopic guidance.
Primary Outcome Measure Information:
Title
Clinical success for pancreatic fluid collections
Description
① Clinical success of pancreatic fluid collections
Peudocyst: resolution more than 50% in the initial size of cyst.
Walled-off necrosis: resolution of PFC without the need for additional interventions after endoscopic interventions.
Time Frame
8 hrs
Title
Clinical success for acute cholecystitis
Description
- Afebrile for 8 hours, tolerating diet, absence of abdominal sign, or 20% decrease in white cell count.
Time Frame
8hrs
Title
Clinical success for obstructive jaundice
Description
- A decrease in total bilirubin to < 50 % of the pre-stenting value within 2 weeks.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Techincal success
Description
- Satisfactory access, placement of stent and drainage.
Time Frame
1 day
Title
Adverse events
Description
Bleeding: any hemorrhagic event during or after the procedure that required endotherapy, radiological interventions, blood product transfusion, or inpatient observation.
Perforation: perforation of the GI tract or cystic wall on imaging studies with peritonitis signs.
Pneumoperitoneum or pneumoretroperitoneum: intraperitoneal or retroperitoneal air on imaging study.
Stent migration: dislocation of the stent into the lumen or the GI tract on imaging study
Time Frame
30 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient must meet all of the following inclusion criteria to be eligible for enrollment into the study.
Pancreatobiliary diseases that are eligible for EUS-guided transenteric drainage
The patient who aged from 20 to 80 years. Legally acceptable representative must be capable of giving written informed consent prior to participation in this study
Target lesion that is accessible through the transenteric approach
The woman of child-bearing age must be negative from the pregnancy test in order to participate in this study
The patient who is willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures
The patients should not have any unacceptable conditions (e.g., physiological, familyism, social, geographical) for medical follow-up and adaptation of the study.
Exclusion Criteria:
Patient presenting with any of the following will not be included in the study.
Inaccessible to EUS-guided approach
Bleeding tendency: International normalized ratio (INR) of prothrombin time < 1.5 or platelet conunt < 60,000/mm3
Patients with Disseminated Intravascular Coagulation syndrome(DIC)
Patients who have been taking medicines that can cause hemorrhage (e.g., Aspirin, Wafarin etc.)
Patients with other serious disease or medical condition
Patients with past medical history of significant neurologic or Psychiatric disorders such as dementia or seizure
Unstable heart disease despite of treatment, recent myocardial infarction within 6 month (Even though MI was diagnosed within 6 months, if it becomes stable presently, the patient can be possible to participate).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Teoh
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese University of Hong Kong
City
Hong Kong
State/Province
Hong Kong
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33284467
Citation
Teoh AYB, Kongkam P, Bapaye A, Ratanachu T, Reknimitr R, Lakthakia S, Chan SM, Gadhikar HP, Korrapati SK, Lee YN, Medarapalem J, Ridtitid W, Moon JH. Use of a novel lumen apposing metallic stent for drainage of the bile duct and gallbladder: Long term outcomes of a prospective international trial. Dig Endosc. 2021 Nov;33(7):1139-1145. doi: 10.1111/den.13911. Epub 2021 Jan 11.
Results Reference
derived
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EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent
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