Treatment of Distal Malignant Biliary Obstruction by Uncovered, Partially Covered, or Fully Covered Metal Stents

NCT06453590 | Active Not Recruiting

• 1 other identifier: 180436
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 12

Brief Summary

The goal of this randomized controlled trial is to compare uncovered, partially covered, and fully covered self-expandable metal stents (SEMS) in the palliative treatment of distal malignant biliary obstruction in a Swedish multicenter study. The main questions it aims to answer is: Is the stent patency rate different depending of stent type? Is the stent patency time different depending of stent type? Is the patient survival different between the groups? Which complications are seen, and do they differ between the groups? Are there different mechanisms behind the stent failure depending on stent type? Patients will at ERCP, with a guidewire passed through the stenosis in the bile duct, be allocated to either uncovered, partially covered, and fully covered (SEMS). Totally, 450 patients will be recruited, 150 in each study arm, according to the power analysis. Patients will be followed in a monthly surveillance by a study nurse up to 12 months after stent insertion. Endpoints are: alive after 12 months with a patent stent, death with a patent stent, stent dysfunction with a subsequent intervention i.e. repeated ERCP or PTC = "objective stent failure", stent dysfunction, jaundice or cholangitis, but not intervention has been undertaken due to a poor condition of the patient, "clinical stent failure", the patient has undergone curative surgery or a bilio-enteric by-pass (a gastro-enteroanastomosis or a duodenal stent is not a reason for exclusion), the patient refuses further follow-up.

Conditions

Pancreatic Cancer Non-resectable; Bile Duct Cancer; Papillary Carcinoma; Duodenal Cancer

Keywords

distal malignant biliary obstruction; ERCP; SEMS; Palliative

Outcome Measures

Primary Outcomes (2)

• Stent patency rate

  Stent patency rate of the three different types of SEMS

  During the follow-up time from insertion of the SEMS (inclusion of the study) until reaching an endpoint (up to 12 months with a patent stent or until stent failure occurs) the rate of patent SEMS in the three different groups is calculated

• Stent patency time

  The time, days, of patency of the SEMS in the three different types of SEMS

  The time, days, of patency of the SEMS during follow-up (up to 12 months) until reaching an endpoint is calculated.

Secondary Outcomes (4)

• Patient survival time

  The time, days, of survival after stent insertion (inclusion in the study) until death, or up to 12 months.

• Mechanisms of stent failure

  During the follow-up, from the time of stent insertion until a stent failure is established (up to 12 months), the reason is analyzed at the time of repeated ERCP

• Adverse events

  During follow-up from the time of stent insertion complications are registered until an endpoint is reached (up to 12 months).

• Difficulty of stent insertion

  This outcome is registered during the ERCP procedure.

Study Arms (3)

Uncovered SEMS

EXPERIMENTAL

Allocated to treatment with an uncovered SEMS in the distal bile duct.

Procedure: Randomization to uncovered SEMS treating jaundice due to distal malignant biliary obstruction.

Partially covered SEMS

EXPERIMENTAL

Allocated to treatment with a partially covered SEMS in the distal bile duct.

Procedure: Randomization to partially covered SEMS treating jaundice due to distal malignant biliary obstruction.

Fully covered SEMS

EXPERIMENTAL

Allocated to treatment with a fully covered SEMS in the distal bile duct.

Procedure: Randomization to fully covered SEMS treating jaundice due to distal malignant biliary obstruction.

Interventions

Randomization to uncovered SEMS treating jaundice due to distal malignant biliary obstruction. PROCEDURE

Patients with jaundice due to distal malignant biliary obstruction in whom surgical resection is not possible are treated at ERCP with metal stents, SEMS. The study is comparing three types of commercially available SEMS, Patients are randomized and allocated to either of three stent types (SEMS), uncovered, partially covered , or fully covered.

Uncovered SEMS

Randomization to partially covered SEMS treating jaundice due to distal malignant biliary obstruction. PROCEDURE

Patients with jaundice due to distal malignant biliary obstruction in whom surgical resection is not possible are treated at ERCP with metal stents, SEMS. The study is comparing three types of commercially available SEMS, Patients are randomized and allocated to either of three stent types (SEMS), uncovered, partially covered , or fully covered.

Partially covered SEMS

Randomization to fully covered SEMS treating jaundice due to distal malignant biliary obstruction. PROCEDURE

Patients with jaundice due to distal malignant biliary obstruction in whom surgical resection is not possible are treated at ERCP with metal stents, SEMS. The study is comparing three types of commercially available SEMS, Patients are randomized and allocated to either of three stent types (SEMS), uncovered, partially covered , or fully covered.

Fully covered SEMS

Eligibility Criteria

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

You may qualify if:

• Patient age \> 20 years.
• The biliary stenosis located \> 2 cm below the hilum of the liver, and with a malignant appearance.
• The patient history, and clinical data supporting a malignant bile duct stenosis.
• S-Bilirubin \> 50 μmol/L.
• Curative surgery or down-staging not possible due to an advanced decease, or surgery is precluded by high age or co-morbidity. Temporary placement of a plastic endoprosthesis allowed, and after reevaluation within 4 weeks the patient may enter the study.
• The patient has received oral and written information about the study and accepted to participate.
• CT and/or Ultrasound has been performed.

You may not qualify if:

• Informed consent has not been obtained or denied.
• The presence of significant intrahepatic stenoses caused by metastatic disease with also intrahepatic obstruction of the bile flow. A malignant stenosis in the hilum of the liver, or a tumor stricture located \< 2cm below the hilum of the liver.
• The patient is probably a candidate for curative surgery or down-staging.
• Suspicion of a benign biliary obstruction.
• Anatomical situation making ERCP impossible i.e. prior surgical interventions or a tumor stenosis of the duodenum. If the ERCP is not successful at the first attempt a repeated procedure or a PTC rendezvouz is allowed within one week.
• Prior biliary drainage (\> 4 weeks earlier).
• Increased risk of bleeding (INR \>1.5)
• The patient has previously been included in the study.

Sponsors & Collaborators

• Region Stockholm: lead

Study Sites (12)

Danderyds hospital

Danderyd, 18288, Sweden

Location

Sahlgrenska University hospital

Gothenburg, 413 45, Sweden

Location

Central Hospital Karlstad

Karlstad, 652 40, Sweden

Location

University Hospital Lund

Lund, 222 42, Sweden

Location

University Hospital Malmö

Malmo, 214 28, Sweden

Location

University Hospital Örebro

Örebro, 701 85, Sweden

Location

Skaraborgs Hospital Skövde

Skövde, 549 49, Sweden

Location

Capio S:t Görans hospital

Stockholm, 112 19, Sweden

Location

Stockholm South Hospital

Stockholm, 118 83, Sweden

Location

University Hospital of Umeå

Umeå, 901 85, Sweden

Location

University hospital Uppsala

Uppsala, 751 85, Sweden

Location

Central Hospital Västerås

Västerås, 721 89, Sweden

Location

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Related Links

• Link to details about cancer incidence i Sweden

MeSH Terms

Conditions

Bile Duct Neoplasms; Carcinoma, Papillary; Duodenal Neoplasms

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Duodenal Diseases; Intestinal Diseases

Study Officials

• Stefan Linder, MD, PhD

  Karolinska university hospital, Karolinska Institutet, Stockholm, Sweden.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial, to either of three groups.

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 11, 2024
• Study Start: February 4, 2020
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Nine months after publication up to 72 months
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose may get access to the data. Individual data used in metaanalyses may be provided.

Locations

SE (12)