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

NCT03002051 | Completed DMC

• 1 other identifier: SPAXUS version 3.0
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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

Conditions

Pancreatic Pseudocyst; Pancreatic Necrosis; Biliary Obstruction; Acute Cholecystitis

Outcome Measures

Primary Outcomes (3)

• 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.

  8 hrs

• Clinical success for acute cholecystitis

  \- Afebrile for 8 hours, tolerating diet, absence of abdominal sign, or 20% decrease in white cell count.

  8hrs

• Clinical success for obstructive jaundice

  \- A decrease in total bilirubin to \< 50 % of the pre-stenting value within 2 weeks.

  2 weeks

Secondary Outcomes (2)

• Techincal success

  1 day

• Adverse events

  30 day

Study Arms (1)

EUS guided drainage

EXPERIMENTAL

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

Device: EUS-guided drainage

Interventions

EUS-guided drainage 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.

EUS guided drainage

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• SoonChunHyang University School of Medicine: collaborator

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, Hong Kong, China

Location

Related Publications (1)

• 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.

  PMID: 33284467 DERIVED

MeSH Terms

Conditions

Pancreatic Pseudocyst; Pancreatitis, Acute Necrotizing; Cholecystitis, Acute

Condition Hierarchy (Ancestors)

Pancreatic Cyst; Cysts; Neoplasms; Pancreatic Diseases; Digestive System Diseases; Pancreatitis; Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases

Study Officials

• Anthony Teoh

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: December 23, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: May 1, 2019
• Last Updated: December 13, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)