NCT06453590Fut, nem toboroz
Treatment of Distal Malignant Biliary Obstruction by Uncovered, Partially Covered, or Fully Covered Metal Stents
Palliative Treatment of Distal Malignant Biliary Obstruction by Endoscopic Stents: Uncovered, Partially Covered, or Fully Covered Metal Stents: A Prospective Randomized Multicenter Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 20.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Fut, nem toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 450 (tervezett)
- Első benyújtás
- 2024. máj. 28.
- Kezdés
- 2020. febr. 4.
- Elsődleges befejezés
- 2027. jan. 15.
- Fő szponzor
- Region Stockholm
- Betegségek
- Hasnyálmirigyrák, Máj- és epeúti rák
- NCT-szám
- NCT06453590
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 450
- 2020. febr. 4. és az elsődleges befejezés (2027. jan. 15.) között
- 12 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Korábbi kezelés
- The patient is probably a candidate for curative surgery or down-staging.
- 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).
- The patient has previously been included in the study.
Más betegség
- 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.
Laborértékek
- Increased risk of bleeding (INR >1.5)
Egyéb
- Informed consent has not been obtained or denied.
- Suspicion of a benign biliary obstruction.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 20 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (12)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.