EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent

NCT ID: NCT03002051

Last Updated: 2019-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2019-05-31

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.

Conditions

Pancreatic Pseudocyst; Pancreatic Necrosis; Biliary Obstruction; Acute Cholecystitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EUS guided drainage

Patients suffering from the conditions in focus would receive EUS guided drainage with the lumen apposing stent

Group Type: EXPERIMENTAL

EUS-guided drainage

Intervention Type: DEVICE

• 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.

Interventions

EUS-guided drainage

• 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SoonChunHyang University School of Medicine

UNKNOWN

Sponsor Role: collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Anthony Teoh

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anthony Teoh

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Chinese University of Hong Kong

Hong Kong, Hong Kong, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 33284467 (View on PubMed)

Other Identifiers

SPAXUS version 3.0

Identifier Type: -

Identifier Source: org_study_id