Malignant Biliary StrictureNCT03530527
Endoscopic Biliary Drainage in Malignant High Grade Biliary Stricture
A study testing ERCP with biliary stenting and EUS guided biliary drainage in people with Malignant Biliary Stricture, run by Prince of Songkla University at 2 sites in Thailand.
Trial summary
Biliary drainage is the mainstay of the palliative treatment in patients with inoperable malignant bile duct stricture. Endoscopic retrograde cholangiopancreatography (ERCP) is the cornerstone of biliary drainage method in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Biliary Stricture
- What is being tested?
- ERCP with biliary stenting and EUS guided biliary drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesThailand
- Study dates
- 20 Aug 2018to 15 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: I) Patients aged > 18 years. II) Clinical, laboratory data, imaging and or histology suggestive of malignant distal bile duct strictures that occurs as a result of pancreatic adenocarcinoma, cholangiocarcinoma, ampullary carcinoma, duodenal carcinoma, gallbladder cancer and metastasis malignant bile duct obstruction III) Inoperability by tumor staging, medically unfit or patient wishes
- distant metastasis
- major vascular involvement (unreconstructible Superior mesenteric vein/Portal vein, superior mesenteric artery, common hepatic artery and celiac artery)
- metastasis to lymphnode beyond the field or surgery IV) Jaundice, total bilirubin ≥15 mg/dl and/ or Common bile duct diameter ≥12 mm
Exclusion Criteria: I) pregnancy II) uncorrectable coagulopathy ( international normalized ratio ≥ 1.5 ) III) thrombocytopenia (platelet count < 50,000 ) IV) extremely poor general condition, ERCP with stent insertion impossible for ethical reasons V) an extension of stricture to the main biliary confluent (hilum) or the existence of obstructive duodenal invasion VI) active suppurative cholangitis VI) surgically altered anatomy (i.e. Billroth II or Roux-en-Y reconstruction ) VII ) previous treatment with bile duct stent.
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
Prince of Songkla University
Hat Yai, Changwat Songkhla, 90230
About this study
Official title: Endoscopic Retrograde Cholangiopancreatography Versus Endoscopic Ultrasound Guided Biliary Drainage in Inoperable Malignant Distal Bile Duct Obstruction
Biliary drainage is the mainstay of the palliative treatment in patients with inoperable malignant bile duct stricture. Endoscopic retrograde cholangiopancreatography (ERCP) is the cornerstone of biliary drainage method in these patients. However, ERCP is sometime unsuccessful to perform because of the presence of the high grade biliary stricture, tumor invasion of duodenum and ampulla of vater and surgically altered gastrointestinal anatomy. Endoscopic ultrasound (EUS) guided biliary drainage has been emerged as an alternative procedure to traditional surgical bypass and percutaneous trans hepatic biliary drainage after failed ERCP. There were few data to directly compare between ERCP and EUS guided biliary drainage and in patients with malignant high grade biliary stricture.
Read the detailed description
The aim of this study is comparing the efficacy and complications between ERCP and EUS guided biliary drainage in patients with malignant high grade biliary stricture. Malignant high grade biliary stricture has not been well defined. The investigators define this malignant high grade biliary stricture using these arbitrary number include total bilirubin ≥ 15 mg/dl and or bile duct diameter ≥12 mm. based on the investigation's experience.
The study will be divided patients with inoperable malignant high grade biliary stricture into 2 groups, group (A) will be undergone ERCP with biliary stenting and group (B) will be undergone EUS guided biliary drainage. If the assigned intervention is not successful, then patients will be crossed-over to the another intervention.
- Conditions
- Malignant Biliary Stricture
- Being tested
- ERCP with biliary stenting, EUS guided biliary drainage
- Keywords
- ERCP, Endoscopic ultrasound (EUS) guided biliary drainage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCP with biliary stentingProcedure or surgery
Also called G1
ERCP with biliary stent is performed using a side view duodenoscope of Olympus (TJF-160). Biliary cannulation is performed using a sphincterotome and 0.035 inch jag wire, and cholangiogarm is done to assess common bile duct diameter, and length of biliary stricture. Biliary sphincterotomy is then performed. A straight biliary stent is placed across stricture bile duct.
EUS guided biliary drainageProcedure or surgery
Also called G2
EUS guided biliary drainage is performed using a linear echoendoscope of Olympus (GFUCT240). Extrahepatic bile duct was identified from duodenal bulb, then 19 G needle is inserted into bile duct with confirmed with cholangiogram. The fistula tract is dilated using a 6 Fr cystotome (Wilson Cook Medical). A double pigtail stent is placed across biliary-enteric fistula.
| Study group | Role | What they receive |
|---|---|---|
| ERCP with biliary stenting | Active comparator | Patient will be undergone ERCP with biliary stenting for biliary decompression to relieve biliary obstruction. Receives: Procedure: ERCP with biliary stenting |
| EUS guided biliary drainage | Active comparator | Patient will be undergone EGBD for biliary decompression to relieve biliary obstruction. Receives: Procedure: EUS guided biliary drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success rate
The number of patients with success of placement of stent in the desired. location
Measured: 24 hours
Secondary outcomes (5)
Clinical success rates
The number of patients with total bilirubin drop more than 30 % compare with baseline after successful biliary stent placement.
Measured: 2 weeks
Total procedure time
The time interval between the intubation of the scope until the placement of the stent
Measured: 24 hours
The complication rates
The number of patients who developed complications related procedure included pancreatitis, bleeding, perforation, cholangitis as defined and graded according to the consensus guideline.
Measured: 4 weeks
The mortality rates
The number of patients with death related to the procedure.
Measured: 1 weeks
Stent patency
The time interval between biliary stent insertion and the need for unscheduled re-interventions.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start20 Aug 2018
- Primary completion28 Nov 2018
- Study completion15 Dec 2019
Why it stopped: The study was terminated because of difficulty in completing the study as originally planned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Biliary StrictureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nisa Netinatsunton, Prince of Songkla University
- Investigators
- Nisa Netinatsunton, MD., Principal investigator, NKC Institute of Gastroenterology and Hepatology, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla, Thailand, 90110.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530527
- Sponsor's protocol ID
- REC 60-277-21-1
- Status last verified
- Mar 2021
- First submitted
- 8 May 2018
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual data of patients participating in the study are not available for public sharing since the investigators did not obtain the consent to share the data of patient.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Retrograde Cholangiopancreatography Versus Endoscopic Ultrasound Guided Biliary Drainage in Inoperable Malignant Distal Bile Duct Obstruction
- ClinicalTrials.gov ID
- NCT03530527
- Acronym / sponsor ID
- REC 60-277-21-1
- Conditions
- Malignant Biliary Stricture
- Keywords
- ERCP, Endoscopic ultrasound (EUS) guided biliary drainage
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated because of difficulty in completing the study as originally planned
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 28 Nov 2018 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 21 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Biliary drainage is the mainstay of the palliative treatment in patients with inoperable malignant bile duct stricture. Endoscopic retrograde cholangiopancreatography (ERCP) is the cornerstone of biliary drainage method in these patients. However, ERCP is sometime unsuccessful to perform because of the presence of the high grade biliary stricture, tumor invasion of duodenum and ampulla of vater and surgically altered gastrointestinal anatomy. Endoscopic ultrasound (EUS) guided biliary drainage has been emerged as an alternative procedure to traditional surgical bypass and percutaneous trans hepatic biliary drainage after failed ERCP. There were few data to directly compare between ERCP and EUS guided biliary drainage and in patients with malignant high grade biliary stricture.
Detailed description
The aim of this study is comparing the efficacy and complications between ERCP and EUS guided biliary drainage in patients with malignant high grade biliary stricture. Malignant high grade biliary stricture has not been well defined. The investigators define this malignant high grade biliary stricture using these arbitrary number include total bilirubin ≥ 15 mg/dl and or bile duct diameter ≥12 mm. based on the investigation's experience.
The study will be divided patients with inoperable malignant high grade biliary stricture into 2 groups, group (A) will be undergone ERCP with biliary stenting and group (B) will be undergone EUS guided biliary drainage. If the assigned intervention is not successful, then patients will be crossed-over to the another intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERCP with biliary stenting | Active comparator | Procedure: ERCP with biliary stentingPatient will be undergone ERCP with biliary stenting for biliary decompression to relieve biliary obstruction. |
| EUS guided biliary drainage | Active comparator | Procedure: EUS guided biliary drainagePatient will be undergone EGBD for biliary decompression to relieve biliary obstruction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERCP with biliary stentingAlso: G1ERCP with biliary stent is performed using a side view duodenoscope of Olympus (TJF-160). Biliary cannulation is performed using a sphincterotome and 0.035 inch jag wire, and cholangiogarm is done to assess common bile duct diameter, and length of biliary stricture. Biliary sphincterotomy is then performed. A straight biliary stent is placed across stricture bile duct. | Procedure or surgery | ERCP with biliary stenting |
| EUS guided biliary drainageAlso: G2EUS guided biliary drainage is performed using a linear echoendoscope of Olympus (GFUCT240). Extrahepatic bile duct was identified from duodenal bulb, then 19 G needle is inserted into bile duct with confirmed with cholangiogram. The fistula tract is dilated using a 6 Fr cystotome (Wilson Cook Medical). A double pigtail stent is placed across biliary-enteric fistula. | Procedure or surgery | EUS guided biliary drainage |
Primary outcome
Technical success rate
Time frame: 24 hours
The number of patients with success of placement of stent in the desired. location
5 secondary outcomes
Clinical success rates
Time frame: 2 weeks
Total procedure time
Time frame: 24 hours
The complication rates
Time frame: 4 weeks
The mortality rates
Time frame: 1 weeks
Stent patency
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: The study was terminated because of difficulty in completing the study as originally planned). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Individual participant dataSharing planned: No. The individual data of patients participating in the study are not available for public sharing since the investigators did not obtain the consent to share the data of patient.
Related trials for Malignant Biliary Stricture
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The HANAROSTENT® Multi-Hole™ Biliary Stent is Indicated for Use in the Palliative Treatment of Biliary Strictures Produced by Malignant Neoplasms and the Study is to Demonstrate Clinical Safety and Performance of the Multi-Hole™ Stent for the Palliative Treatment of Malignant Biliary Obstruction.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nisa Netinatsunton, MD. principal investigator
NKC Institute of Gastroenterology and Hepatology, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla, Thailand, 90110.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERCP with biliary stenting and EUS guided biliary drainage in people with Malignant Biliary Stricture, run by Prince of Songkla University at 2 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was terminated because of difficulty in completing the study as originally planned). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success rate (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.