Biliary ObstructionMETARSINCT04431427
Partially Covered Metal Stents Efficacy in Biliary Drainage of Malignant Extra-hepatic Biliary Obstruction
A study testing Biliary drainage with PC-SEMS and Biliary drainage with U-SEMS in people with Biliary Obstruction, run by Santi Mangiafico.
Trial summary
Malignant obstructions of the bile duct are not rare. The most common and accepted method for biliary drainage is endoscopic stent placement. There are three types of metal stents: fully covered (FC), partially covered (PC) and uncovered (U). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Obstruction
- What is being tested?
- Biliary drainage with PC-SEMS and Biliary drainage with U-SEMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Feb 2021to Aug 2022
- 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
Who may be able to join
- •The patients who had malignant biliary obstruction with a estimated survival >4 months
Who cannot join
- The patients who had resectable biliary malignancy
- The patients who had hilar obstruction
- The patients who had duodenal obstruction
- The patients who had International Normalized Ratio (INR)>1.5
- The patients who did not give informed consent
- The patients who had technically difficult structure for Endoscopic retrograde cholangiopancreatography (ERCP)
Trial locations and contacts
No sites are listed yet.
Santi Mangiafico, MD contact
About this study
Official title: Partially Covered Metal Stents Efficacy in the Biliary Drainage of Malignant Extra-hepatic Biliary Obstruction, a Multicentric Randomized Trial
Malignant obstructions of the bile duct are not rare. The most common and accepted method for biliary drainage is endoscopic stent placement. There are three types of metal stents: fully covered (FC), partially covered (PC) and uncovered (U). PC-SEMS have been recently introduced and compared to FC-SEMS they seem to have a lower risk of migration, although data in the literature are discordant. Therefore the investigators will randomize the participants with biliary obstruction in 2 groups according to the type of stent used: PC-SEMS or U-SEMS. After metallic biliary stent insertion, enrolled patients will be followed for 12 months.
Read the detailed description
Malignant obstructions of the bile duct are generally caused by: adenocarcinoma of the Vater ampulla, pancreas head cancer, cholangiocarcinoma and external compression secondary to lymph node (LN) metastasis. The management of jaundice and cholangitis, as a result of bile stenosis, is crucial in this group of patients. The most common and accepted method for biliary drainage is endoscopic stent placement with plastic stents or self-expandable metal stents (SEMS). In recent times, the use of SEMS has become more common as it provides longer times of patency and a reduced risk of adverse events such as cholangitic episodes. There are three types of metal stents: fully covered (FC), partially covered (PC) and uncovered (U). PC-SEMS have been recently introduced and compared to FC-SEMS they seem to have a lower risk of migration, however different randomized and non-randomized studies have compared the outcome of U-SEMS vs FC-SEMS with between uncovered and covered stents have produced different results regarding the cumulative patency of stents and endoscopic re-intervention rates. To date, there are few and discordant prospective data on the outcomes of PC-SEMS use in malignant biliary obstructions.
Therefore, the investigators will randomize the participants with biliary obstruction in 2 groups according to the type of stent used: PC-SEMS or U-SEMS (T0 timing).
Then the participants will be followed for total period of 12 months. 2 different timings of follow-up will be considered:
- T1: it will start after stent insertion. The biliary drainage will be considered effective, according to the European guidelines, when the bilirubin values will be < or = 2 mg/dl for a period of at least 6 weeks if the initial bilirubin values were higher than 10 mg/dl or 3 weeks if at the beginning were lower than 10 mg/dl; After this first phase, all the enrolled patients will be divided in 2 groups according to their "fitness" for chemiotherapy: FIT and UNFIT Group.
FIT group: blood test (including total bilirubin, gamma-GT) will be done for follow-up study once every three months.
UNFIT Group: blood test (including total bilirubin, gamma-GT) will be done for follow-up study after 3, 9 and 12 months.
- Conditions
- Biliary Obstruction
- Being tested
- Biliary drainage with PC-SEMS, Biliary drainage with U-SEMS
- Keywords
- Malignant biliary obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biliary drainage with PC-SEMSDevice
partially covered metallic biliary stent insertion during ERCP
Biliary drainage with U-SEMSDevice
Uncovered metallic biliary stent insertion during ERCP
| Study group | Role | What they receive |
|---|---|---|
| Partially Covered Metal Stent Arm | Active comparator | The patients who had extra-hepatic malignant biliary obstruction will be enrolled in our study. Enrolled patient will be randomized to two group (uncovered metallic stent vs. partially covered metallic stent). After metallic biliary stent insertion, enrolled patients will be followed until bilirubin values will be under 2 mg/dl. Receives: Device: Biliary drainage with PC-SEMS |
| Uncovered Metal Stent Arm | Active comparator | The patients who had extra-hepatic malignant biliary obstruction will be enrolled in our study. Enrolled patient will be randomized to two group (uncovered metallic stent vs. partially covered metallic stent). After metallic biliary stent insertion, enrolled patients will be followed until bilirubin values will be under 2 mg/dl. Receives: Device: Biliary drainage with U-SEMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-intervention rate
Evaluation in both arms of the re-intervention rate considered as any procedure needed for a new drainage of the biliary tree, endoscopic or percutaneous, to replace a dysfunctional stent.
Measured: 12 months
Secondary outcomes (1)
Evaluation of patency, migration and adverse events rate
evaluation of patency, migration and adverse events rate for each arm
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study startFeb 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Biliary ObstructionStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Santi Mangiafico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Santi Mangiafico, Azienda Ospedaliero-Universitaria di Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431427
- Sponsor's protocol ID
- 05.2020
- Acronym
- METARSI
- Status last verified
- Jan 2021
- First submitted
- 11 Jun 2020
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bowlus CL, Olson KA, Gershwin ME. Evaluation of indeterminate biliary strictures. Nat Rev Gastroenterol Hepatol. 2016 Jan;13(1):28-37. doi: 10.1038/nrgastro.2015.182. Epub 2015 Nov 3.
PubMed 26526122Reisman Y, Gips CH, Lavelle SM, Wilson JH. Clinical presentation of (subclinical) jaundice--the Euricterus project in The Netherlands. United Dutch Hospitals and Euricterus Project Management Group. Hepatogastroenterology. 1996 Sep-Oct;43(11):1190-5.
PubMed 8908550Zorron Pu L, de Moura EG, Bernardo WM, Baracat FI, Mendonca EQ, Kondo A, Luz GO, Furuya Junior CK, Artifon EL. Endoscopic stenting for inoperable malignant biliary obstruction: A systematic review and meta-analysis. World J Gastroenterol. 2015 Dec 21;21(47):13374-85. doi: 10.3748/wjg.v21.i47.13374.
PubMed 26715823Dumonceau JM, Tringali A, Papanikolaou IS, Blero D, Mangiavillano B, Schmidt A, Vanbiervliet G, Costamagna G, Deviere J, Garcia-Cano J, Gyokeres T, Hassan C, Prat F, Siersema PD, van Hooft JE. Endoscopic biliary stenting: indications, choice of stents, and results: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline - Updated October 2017. Endoscopy. 2018 Sep;50(9):910-930. doi: 10.1055/a-0659-9864. Epub 2018 Aug 7.
PubMed 30086596Crippa S, Cirocchi R, Partelli S, Petrone MC, Muffatti F, Renzi C, Falconi M, Arcidiacono PG. Systematic review and meta-analysis of metal versus plastic stents for preoperative biliary drainage in resectable periampullary or pancreatic head tumors. Eur J Surg Oncol. 2016 Sep;42(9):1278-85. doi: 10.1016/j.ejso.2016.05.001. Epub 2016 May 24.
PubMed 27296728Mukai T, Yasuda I, Nakashima M, Doi S, Iwashita T, Iwata K, Kato T, Tomita E, Moriwaki H. Metallic stents are more efficacious than plastic stents in unresectable malignant hilar biliary strictures: a randomized controlled trial. J Hepatobiliary Pancreat Sci. 2013 Feb;20(2):214-22. doi: 10.1007/s00534-012-0508-8.
PubMed 22415652Tsuboi T, Sasaki T, Serikawa M, Ishii Y, Mouri T, Shimizu A, Kurihara K, Tatsukawa Y, Miyaki E, Kawamura R, Tsushima K, Murakami Y, Uemura K, Chayama K. Preoperative Biliary Drainage in Cases of Borderline Resectable Pancreatic Cancer Treated with Neoadjuvant Chemotherapy and Surgery. Gastroenterol Res Pract. 2016;2016:7968201. doi: 10.1155/2016/7968201. Epub 2016 Jan 6.
PubMed 26880897Yang MJ, Kim JH, Yoo BM, Hwang JC, Yoo JH, Lee KS, Kang JK, Kim SS, Lim SG, Shin SJ, Cheong JY, Lee KM, Lee KJ, Cho SW. Partially covered versus uncovered self-expandable nitinol stents with anti-migration properties for the palliation of malignant distal biliary obstruction: A randomized controlled trial. Scand J Gastroenterol. 2015;50(12):1490-9. doi: 10.3109/00365521.2015.1057219. Epub 2015 Jul 1.
PubMed 26133200Kitano M, Yamashita Y, Tanaka K, Konishi H, Yazumi S, Nakai Y, Nishiyama O, Uehara H, Mitoro A, Sanuki T, Takaoka M, Koshitani T, Arisaka Y, Shiba M, Hoki N, Sato H, Sasaki Y, Sato M, Hasegawa K, Kawabata H, Okabe Y, Mukai H. Covered self-expandable metal stents with an anti-migration system improve patency duration without increased complications compared with uncovered stents for distal biliary obstruction caused by pancreatic carcinoma: a randomized multicenter trial. Am J Gastroenterol. 2013 Nov;108(11):1713-22. doi: 10.1038/ajg.2013.305. Epub 2013 Sep 17.
PubMed 24042190Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.
PubMed 31863440
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partially Covered Metal Stents Efficacy in the Biliary Drainage of Malignant Extra-hepatic Biliary Obstruction, a Multicentric Randomized Trial
- ClinicalTrials.gov ID
- NCT04431427
- Acronym / sponsor ID
- METARSI / 05.2020
- Conditions
- Biliary Obstruction
- Keywords
- Malignant biliary obstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Santi MangiaficoUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 16 Jun 2020 (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.
Malignant obstructions of the bile duct are not rare. The most common and accepted method for biliary drainage is endoscopic stent placement. There are three types of metal stents: fully covered (FC), partially covered (PC) and uncovered (U). PC-SEMS have been recently introduced and compared to FC-SEMS they seem to have a lower risk of migration, although data in the literature are discordant. Therefore the investigators will randomize the participants with biliary obstruction in 2 groups according to the type of stent used: PC-SEMS or U-SEMS. After metallic biliary stent insertion, enrolled patients will be followed for 12 months.
Detailed description
Malignant obstructions of the bile duct are generally caused by: adenocarcinoma of the Vater ampulla, pancreas head cancer, cholangiocarcinoma and external compression secondary to lymph node (LN) metastasis. The management of jaundice and cholangitis, as a result of bile stenosis, is crucial in this group of patients. The most common and accepted method for biliary drainage is endoscopic stent placement with plastic stents or self-expandable metal stents (SEMS). In recent times, the use of SEMS has become more common as it provides longer times of patency and a reduced risk of adverse events such as cholangitic episodes. There are three types of metal stents: fully covered (FC), partially covered (PC) and uncovered (U). PC-SEMS have been recently introduced and compared to FC-SEMS they seem to have a lower risk of migration, however different randomized and non-randomized studies have compared the outcome of U-SEMS vs FC-SEMS with between uncovered and covered stents have produced different results regarding the cumulative patency of stents and endoscopic re-intervention rates. To date, there are few and discordant prospective data on the outcomes of PC-SEMS use in malignant biliary obstructions.
Therefore, the investigators will randomize the participants with biliary obstruction in 2 groups according to the type of stent used: PC-SEMS or U-SEMS (T0 timing).
Then the participants will be followed for total period of 12 months. 2 different timings of follow-up will be considered:
- T1: it will start after stent insertion. The biliary drainage will be considered effective, according to the European guidelines, when the bilirubin values will be < or = 2 mg/dl for a period of at least 6 weeks if the initial bilirubin values were higher than 10 mg/dl or 3 weeks if at the beginning were lower than 10 mg/dl; After this first phase, all the enrolled patients will be divided in 2 groups according to their "fitness" for chemiotherapy: FIT and UNFIT Group.
FIT group: blood test (including total bilirubin, gamma-GT) will be done for follow-up study once every three months.
UNFIT Group: blood test (including total bilirubin, gamma-GT) will be done for follow-up study after 3, 9 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partially Covered Metal Stent Arm | Active comparator | Device: Biliary drainage with PC-SEMSThe patients who had extra-hepatic malignant biliary obstruction will be enrolled in our study. Enrolled patient will be randomized to two group (uncovered metallic stent vs. partially covered metallic stent). After metallic biliary stent insertion, enrolled patients will be followed until bilirubin values will be under 2 mg/dl. |
| Uncovered Metal Stent Arm | Active comparator | Device: Biliary drainage with U-SEMSThe patients who had extra-hepatic malignant biliary obstruction will be enrolled in our study. Enrolled patient will be randomized to two group (uncovered metallic stent vs. partially covered metallic stent). After metallic biliary stent insertion, enrolled patients will be followed until bilirubin values will be under 2 mg/dl. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- •The patients who had malignant biliary obstruction with a estimated survival >4 months
Key exclusion criteria (6 listed)
- The patients who had resectable biliary malignancy
- The patients who had hilar obstruction
- The patients who had duodenal obstruction
- The patients who had International Normalized Ratio (INR)>1.5
- The patients who did not give informed consent
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 |
|---|---|---|
| Biliary drainage with PC-SEMSpartially covered metallic biliary stent insertion during ERCP | Device | Partially Covered Metal Stent Arm |
| Biliary drainage with U-SEMSUncovered metallic biliary stent insertion during ERCP | Device | Uncovered Metal Stent Arm |
Primary outcome
Re-intervention rate
Time frame: 12 months
Evaluation in both arms of the re-intervention rate considered as any procedure needed for a new drainage of the biliary tree, endoscopic or percutaneous, to replace a dysfunctional stent.
1 secondary outcome
Evaluation of patency, migration and adverse events rate
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Results publication: PubMed 26526122Bowlus CL, Olson KA, Gershwin ME. Evaluation of indeterminate biliary strictures. Nat Rev Gastroenterol Hepatol. 2016 Jan;13(1):28-37. doi: 10.1038/nrgastro.2015.182. Epub 2015 Nov 3.
- Results publication: PubMed 8908550Reisman Y, Gips CH, Lavelle SM, Wilson JH. Clinical presentation of (subclinical) jaundice--the Euricterus project in The Netherlands. United Dutch Hospitals and Euricterus Project Management Group. Hepatogastroenterology. 1996 Sep-Oct;43(11):1190-5.
- Results publication: PubMed 26715823Zorron Pu L, de Moura EG, Bernardo WM, Baracat FI, Mendonca EQ, Kondo A, Luz GO, Furuya Junior CK, Artifon EL. Endoscopic stenting for inoperable malignant biliary obstruction: A systematic review and meta-analysis. World J Gastroenterol. 2015 Dec 21;21(47):13374-85. doi: 10.3748/wjg.v21.i47.13374.
- Results publication: PubMed 30086596Dumonceau JM, Tringali A, Papanikolaou IS, Blero D, Mangiavillano B, Schmidt A, Vanbiervliet G, Costamagna G, Deviere J, Garcia-Cano J, Gyokeres T, Hassan C, Prat F, Siersema PD, van Hooft JE. Endoscopic biliary stenting: indications, choice of stents, and results: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline - Updated October 2017. Endoscopy. 2018 Sep;50(9):910-930. doi: 10.1055/a-0659-9864. Epub 2018 Aug 7.
- Results publication: PubMed 27296728Crippa S, Cirocchi R, Partelli S, Petrone MC, Muffatti F, Renzi C, Falconi M, Arcidiacono PG. Systematic review and meta-analysis of metal versus plastic stents for preoperative biliary drainage in resectable periampullary or pancreatic head tumors. Eur J Surg Oncol. 2016 Sep;42(9):1278-85. doi: 10.1016/j.ejso.2016.05.001. Epub 2016 May 24.
- Results publication: PubMed 22415652Mukai T, Yasuda I, Nakashima M, Doi S, Iwashita T, Iwata K, Kato T, Tomita E, Moriwaki H. Metallic stents are more efficacious than plastic stents in unresectable malignant hilar biliary strictures: a randomized controlled trial. J Hepatobiliary Pancreat Sci. 2013 Feb;20(2):214-22. doi: 10.1007/s00534-012-0508-8.
- Results publication: PubMed 26880897Tsuboi T, Sasaki T, Serikawa M, Ishii Y, Mouri T, Shimizu A, Kurihara K, Tatsukawa Y, Miyaki E, Kawamura R, Tsushima K, Murakami Y, Uemura K, Chayama K. Preoperative Biliary Drainage in Cases of Borderline Resectable Pancreatic Cancer Treated with Neoadjuvant Chemotherapy and Surgery. Gastroenterol Res Pract. 2016;2016:7968201. doi: 10.1155/2016/7968201. Epub 2016 Jan 6.
- Results publication: PubMed 26133200Yang MJ, Kim JH, Yoo BM, Hwang JC, Yoo JH, Lee KS, Kang JK, Kim SS, Lim SG, Shin SJ, Cheong JY, Lee KM, Lee KJ, Cho SW. Partially covered versus uncovered self-expandable nitinol stents with anti-migration properties for the palliation of malignant distal biliary obstruction: A randomized controlled trial. Scand J Gastroenterol. 2015;50(12):1490-9. doi: 10.3109/00365521.2015.1057219. Epub 2015 Jul 1.
- Results publication: PubMed 24042190Kitano M, Yamashita Y, Tanaka K, Konishi H, Yazumi S, Nakai Y, Nishiyama O, Uehara H, Mitoro A, Sanuki T, Takaoka M, Koshitani T, Arisaka Y, Shiba M, Hoki N, Sato H, Sasaki Y, Sato M, Hasegawa K, Kawabata H, Okabe Y, Mukai H. Covered self-expandable metal stents with an anti-migration system improve patency duration without increased complications compared with uncovered stents for distal biliary obstruction caused by pancreatic carcinoma: a randomized multicenter trial. Am J Gastroenterol. 2013 Nov;108(11):1713-22. doi: 10.1038/ajg.2013.305. Epub 2013 Sep 17.
- Results publication: PubMed 31863440Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.
- Individual participant dataSharing planned: No
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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.
Santi Mangiafico, MD contact
Questions about this trial
What is this clinical trial studying?
A study testing Biliary drainage with PC-SEMS and Biliary drainage with U-SEMS in people with Biliary Obstruction, run by Santi Mangiafico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SILVIA COCCA, MD (00393756213301, cocca.silvia@aou.mo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-intervention rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04431427, which also lists 10 linked publications.
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 20 Jan 2021.