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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

About this trial

This is an interventional treatment trial for Pancreatic Pseudocyst

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

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

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

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

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