Primary percutaneous stenting above the ampulla versus endoscopic drainage for unresectable malignant hilar biliary obstruction (TESLA RCT): study protocol for a multicenter randomized controlled trial
Abstract Background Patients with malignant hilar biliary obstruction typically present with painless jaundice. They commonly have perihilar cholangiocarcinoma (pCCA), but also intrahepatic cholangiocarcinoma, gallbladder cancer, and metastases to the liver hilum can present with hilar biliary obstr...
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2025-05-01
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| author | M. Rousian V. van Verschuer S. Franssen D. Bijdevaate R. P.H. Bokkers A. E. Braat J. de Bruijne M. J. Bruno M. C. Burgmans O. M. van Delden M. Dewulf J. I. Erdmann J. Hagendoorn B. van der Holt F. J.H. Hoogwater A. Inderson C. van der Leij B. Mohseny J. W. Poley M. L.J. Smits F. G.I. van Vilsteren R. P. Voermans I. A.J. Zijlstra L. M.J.W. van Driel B. Groot Koerkamp |
| author_facet | M. Rousian V. van Verschuer S. Franssen D. Bijdevaate R. P.H. Bokkers A. E. Braat J. de Bruijne M. J. Bruno M. C. Burgmans O. M. van Delden M. Dewulf J. I. Erdmann J. Hagendoorn B. van der Holt F. J.H. Hoogwater A. Inderson C. van der Leij B. Mohseny J. W. Poley M. L.J. Smits F. G.I. van Vilsteren R. P. Voermans I. A.J. Zijlstra L. M.J.W. van Driel B. Groot Koerkamp |
| author_sort | M. Rousian |
| collection | DOAJ |
| description | Abstract Background Patients with malignant hilar biliary obstruction typically present with painless jaundice. They commonly have perihilar cholangiocarcinoma (pCCA), but also intrahepatic cholangiocarcinoma, gallbladder cancer, and metastases to the liver hilum can present with hilar biliary obstruction. Endoscopic biliary drainage is the standard of care in most centers. Many patients develop drainage-related complications after endoscopic biliary drainage for malignant hilar biliary obstruction, in particular cholangitis, resulting in reinterventions, clinical deterioration and a high mortality rate. Primary percutaneous stenting (PPS) aims to avoid bacterial contamination and reduce drainage-related complications. The aim of this randomized controlled trial is to compare PPS with endoscopic biliary drainage in patients with unresectable malignant hilar biliary obstruction. Methods This multicenter phase 3 randomized controlled trial (TESLA RCT) will recruit 148 patients with unresectable malignant hilar biliary obstruction in six Dutch tertiary academic referral centers. Diagnosis of malignant hilar biliary obstruction is pathologically confirmed or determined as very likely by the multidisciplinary team. In the intervention arm, patients undergo primary percutaneous stenting with uncovered self-expandable metal stents without crossing the ampulla and without leaving an external drain. In the control arm patients undergo endoscopic biliary drainage according to international guidelines. The primary endpoint is major complications within 90 days after randomization. Secondary outcomes include technical success, reintervention rates, decrease of bilirubin levels, eligibility for palliative systemic treatment, quality of life, and overall survival. Discussion The multicenter TESLA RCT compares primary percutaneous stenting with endoscopic biliary drainage in patients with unresectable malignant hilar biliary obstruction. First patient was randomized on August 9, 2023. Trial registration Netherlands Trial Register (NL-OMON53463), registered on May 12, 2023, and Clinicaltrials.gov (NCT06671418), registered on November 1, 2024. |
| format | Article |
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| institution | OA Journals |
| issn | 1471-2407 |
| language | English |
| publishDate | 2025-05-01 |
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| spelling | doaj-art-2cd246d1794e444fbc137dbd21b251a52025-08-20T02:15:12ZengBMCBMC Cancer1471-24072025-05-012511810.1186/s12885-025-14158-0Primary percutaneous stenting above the ampulla versus endoscopic drainage for unresectable malignant hilar biliary obstruction (TESLA RCT): study protocol for a multicenter randomized controlled trialM. Rousian0V. van Verschuer1S. Franssen2D. Bijdevaate3R. P.H. Bokkers4A. E. Braat5J. de Bruijne6M. J. Bruno7M. C. Burgmans8O. M. van Delden9M. Dewulf10J. I. Erdmann11J. Hagendoorn12B. van der Holt13F. J.H. Hoogwater14A. Inderson15C. van der Leij16B. Mohseny17J. W. Poley18M. L.J. Smits19F. G.I. van Vilsteren20R. P. Voermans21I. A.J. Zijlstra22L. M.J.W. van Driel23B. Groot Koerkamp24Department of Surgery, Erasmus MC Cancer InstituteDepartment of Surgery, Erasmus MC Cancer InstituteDepartment of Radiology, UMC Utrecht, University Medical CenterDepartment of Interventional Radiology, Erasmus MC, University Medical CenterDepartment of Interventional Radiology, UMC Groningen, University Medical CenterDepartment of Surgery, Leiden UMC, University Medical CenterDepartment of Gastroenterology and Hepatology, UMC Utrecht, University Medical CenterDepartment of Gastroenterology and Hepatology, Erasmus MC, University Medical CenterDepartment of Interventional Radiology, Leiden UMC, University Medical CenterDepartment of Gastroenterology and Hepatology, Amsterdam University Medical center, University of AmsterdamDepartment of Surgery, Maastricht UMC, University Medical CenterDepartment of Surgery, Amsterdam University Medical center, University of AmsterdamDepartment of Surgery, UMC Utrecht, University Medical CenterDepartment of Hematology, Erasmus MC, University Medical CenterDepartment of Surgery, UMC Groningen, University Medical CenterDepartment of Gastroenterology and Hepatology, Leiden UMC, University Medical CenterDepartment of Interventional Radiology, Maastricht UMC, University Medical CenterDepartment of Interventional Radiology, Erasmus MC, University Medical CenterDepartment of Gastroenterology and Hepatology, Maastricht UMC, University Medical CenterDepartment of Interventional Radiology, UMC Utrecht, University Medical CenterDepartment of Gastroenterology and Hepatology, UMC Groningen, University Medical CenterDepartment of Gastroenterology and Hepatology, Amsterdam University Medical center, University of AmsterdamDepartment of Interventional Radiology, Amsterdam University Medical center, University of AmsterdamDepartment of Gastroenterology and Hepatology, Erasmus MC, University Medical CenterDepartment of Surgery, Erasmus MC Cancer InstituteAbstract Background Patients with malignant hilar biliary obstruction typically present with painless jaundice. They commonly have perihilar cholangiocarcinoma (pCCA), but also intrahepatic cholangiocarcinoma, gallbladder cancer, and metastases to the liver hilum can present with hilar biliary obstruction. Endoscopic biliary drainage is the standard of care in most centers. Many patients develop drainage-related complications after endoscopic biliary drainage for malignant hilar biliary obstruction, in particular cholangitis, resulting in reinterventions, clinical deterioration and a high mortality rate. Primary percutaneous stenting (PPS) aims to avoid bacterial contamination and reduce drainage-related complications. The aim of this randomized controlled trial is to compare PPS with endoscopic biliary drainage in patients with unresectable malignant hilar biliary obstruction. Methods This multicenter phase 3 randomized controlled trial (TESLA RCT) will recruit 148 patients with unresectable malignant hilar biliary obstruction in six Dutch tertiary academic referral centers. Diagnosis of malignant hilar biliary obstruction is pathologically confirmed or determined as very likely by the multidisciplinary team. In the intervention arm, patients undergo primary percutaneous stenting with uncovered self-expandable metal stents without crossing the ampulla and without leaving an external drain. In the control arm patients undergo endoscopic biliary drainage according to international guidelines. The primary endpoint is major complications within 90 days after randomization. Secondary outcomes include technical success, reintervention rates, decrease of bilirubin levels, eligibility for palliative systemic treatment, quality of life, and overall survival. Discussion The multicenter TESLA RCT compares primary percutaneous stenting with endoscopic biliary drainage in patients with unresectable malignant hilar biliary obstruction. First patient was randomized on August 9, 2023. Trial registration Netherlands Trial Register (NL-OMON53463), registered on May 12, 2023, and Clinicaltrials.gov (NCT06671418), registered on November 1, 2024.https://doi.org/10.1186/s12885-025-14158-0Malignant hilar biliary obstructionPrimary percutaneous stentingEndoscopic biliary drainageRandomized controlled trialMajor complicationsOverall survival |
| spellingShingle | M. Rousian V. van Verschuer S. Franssen D. Bijdevaate R. P.H. Bokkers A. E. Braat J. de Bruijne M. J. Bruno M. C. Burgmans O. M. van Delden M. Dewulf J. I. Erdmann J. Hagendoorn B. van der Holt F. J.H. Hoogwater A. Inderson C. van der Leij B. Mohseny J. W. Poley M. L.J. Smits F. G.I. van Vilsteren R. P. Voermans I. A.J. Zijlstra L. M.J.W. van Driel B. Groot Koerkamp Primary percutaneous stenting above the ampulla versus endoscopic drainage for unresectable malignant hilar biliary obstruction (TESLA RCT): study protocol for a multicenter randomized controlled trial BMC Cancer Malignant hilar biliary obstruction Primary percutaneous stenting Endoscopic biliary drainage Randomized controlled trial Major complications Overall survival |
| title | Primary percutaneous stenting above the ampulla versus endoscopic drainage for unresectable malignant hilar biliary obstruction (TESLA RCT): study protocol for a multicenter randomized controlled trial |
| title_full | Primary percutaneous stenting above the ampulla versus endoscopic drainage for unresectable malignant hilar biliary obstruction (TESLA RCT): study protocol for a multicenter randomized controlled trial |
| title_fullStr | Primary percutaneous stenting above the ampulla versus endoscopic drainage for unresectable malignant hilar biliary obstruction (TESLA RCT): study protocol for a multicenter randomized controlled trial |
| title_full_unstemmed | Primary percutaneous stenting above the ampulla versus endoscopic drainage for unresectable malignant hilar biliary obstruction (TESLA RCT): study protocol for a multicenter randomized controlled trial |
| title_short | Primary percutaneous stenting above the ampulla versus endoscopic drainage for unresectable malignant hilar biliary obstruction (TESLA RCT): study protocol for a multicenter randomized controlled trial |
| title_sort | primary percutaneous stenting above the ampulla versus endoscopic drainage for unresectable malignant hilar biliary obstruction tesla rct study protocol for a multicenter randomized controlled trial |
| topic | Malignant hilar biliary obstruction Primary percutaneous stenting Endoscopic biliary drainage Randomized controlled trial Major complications Overall survival |
| url | https://doi.org/10.1186/s12885-025-14158-0 |
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