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New study compares two drainage techniques to ease jaundice in advanced cancer patients

NCT ID NCT06375967

Symptom relief Sponsor: Hospital Universitari de Bellvitge Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two minimally invasive procedures to drain blocked bile ducts in patients with incurable cancer. One method drains the bile duct into the intestine, the other drains the gallbladder into the stomach. The goal is to see which approach causes fewer complications and keeps the bile flowing longer. The trial involves 128 palliative patients and is currently on hold.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)
What this could lead to
If successful, this could identify the safer and more effective drainage method for relieving jaundice in patients with incurable bile duct or pancreatic cancer.
What could go wrong
This trial is currently suspended, and it only includes palliative patients, so results may not apply to earlier-stage disease. Both procedures carry risks like infection or stent blockage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 128 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Malignant distal biliary obstruction diagnosed in patient considered PALIATIVE with biliary drainage indication. * Consensual malignancy by a bilio-pancreatic multidisciplinar committe (histological confirmation is not mandatory) * Patient capable of understanding and/or singning the informed consent. * Patient who understands the type of study and will comply with all follow-up tests throughout its duration Exclusion Criteria: * Pregnancy or lactation. * Severe coagulation disorder: INR \> 1.5 non correctable with plasma administration and/or platelet count \< 50.000/mm3. * Previous cholecistectomy or gallblader perforation. * Tumoral obstruction of cystic duct. * Multiple liver metastases affecting more than 30% of the liver parenchyma * Distal malignant biliary strictures in patients considered resectable or borderline. * Benign or uncertain etiology of biliary strictures or strictures located proximally or in close proximity to the hilum. * Patients with prior biliary stents or other biliary drainages (e.g., PTCD). * Altered intestinal anatomy due to prior surgery that prevents or hinders papillary access \_\_\_\_\_\_\_\_\_\_\_\_\_\_ (e.g., gastric bypass, Billroth II, duodenal switch, Roux-en-Y). * Gastric outlet obstruction. * Situations that do not allow for upper gastrointestinal endoscopy (e.g., esophageal stricture). * Patients with functional diversity, who lack the capacity to understand the nature and potential consequences of the study, except when a legal representative is available. * Patients incapable of maintaining follow-up appointments (lack of adherence). * Lack of informed consent.

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Conditions

The condition(s) this trial relates to.

biliary tract neoplasm Biliary Tract Neoplasms distal biliary tract carcinoma malignant pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Biliary tract neoplasms Malignant biliary obstruction Pancreatic cancer non-resectable

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Complejo Hospitalario de Pamplona

    Pamplona, Spain

  • Hospital Clinic de Valencia

    Valencia, Spain

  • Hospital Cunqueiro de Vigo

    Vigo, Spain

  • Hospital General Alicante

    Alicante, Valencia, Spain

  • Hospital Mutua de Terrassa

    Terrassa, Spain

  • Hospital Santa Creu I Sant Pau

    Barcelona, Spain

  • Hospital Santiago de Compostela

    Santiago de Compostela, Spain

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, BARCELONA, 08907, Spain

  • Hospital Universitari de Castello

    Castellon, Valencia, Spain

  • Hospital Virgen de Las Nieves

    Granada, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.