Evidence map›Paper›PMID 40346549›Full record

ArticleBMC cancer2025

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.

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 and 15 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06671418 (Primary Percutaneous Stenting Above the Ampulla Versus Endoscopic Drainage for Unresectable Malignant Hilar Biliary Obstruction), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06671418 phase3enrolling by invitationnot on this map

Primary Percutaneous Stenting Above the Ampulla Versus Endoscopic Drainage for Unresectable Malignant Hilar Biliary Obstruction (TESLA RCT)

TypeinterventionalSponsorErasmus Medical CenterRan2023 to 2027Enrolled148ConditionsCholangiocarcinoma Non-resectable, Gall Bladder Cancer, Liver Metastasis, Malignant Hilar StrictureArmsPrimary percutaneous stenting (PPS), Endoscopic biliary drainage
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. [Klatskin tumors-differentiated surgical treatment].Chirurgie (Heidelberg, Germany) · 2026
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors.

M RousianDepartment of Surgery, Erasmus MC Cancer Institute, Rotterdam, The Netherlands. m.rousian.1@erasmusmc.nl.
V van VerschuerDepartment of Surgery, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
S FranssenDepartment of Radiology, UMC Utrecht, University Medical Center, Utrecht, The Netherlands.
D BijdevaateDepartment of Interventional Radiology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.
R P H BokkersDepartment of Interventional Radiology, UMC Groningen, University Medical Center, Groningen, The Netherlands.
A E BraatDepartment of Surgery, Leiden UMC, University Medical Center, Leiden, The Netherlands.
J de BruijneDepartment of Gastroenterology and Hepatology, UMC Utrecht, University Medical Center, Utrecht, The Netherlands.
M J BrunoDepartment of Gastroenterology and Hepatology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.
M C BurgmansDepartment of Interventional Radiology, Leiden UMC, University Medical Center, Leiden, The Netherlands.
O M van DeldenDepartment of Gastroenterology and Hepatology, Amsterdam University Medical center, University of Amsterdam, Amsterdam, The Netherlands.
M DewulfDepartment of Surgery, Maastricht UMC, University Medical Center, Maastricht, The Netherlands.
J I ErdmannDepartment of Surgery, Amsterdam University Medical center, University of Amsterdam, Amsterdam, The Netherlands.
J HagendoornDepartment of Surgery, UMC Utrecht, University Medical Center, Utrecht, The Netherlands.
B van der HoltDepartment of Hematology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.
F J H HoogwaterDepartment of Surgery, UMC Groningen, University Medical Center, Groningen, The Netherlands.
A IndersonDepartment of Gastroenterology and Hepatology, Leiden UMC, University Medical Center, Leiden, The Netherlands.
C van der LeijDepartment of Interventional Radiology, Maastricht UMC, University Medical Center, Maastricht, The Netherlands.
B MohsenyDepartment of Interventional Radiology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.
J W PoleyDepartment of Gastroenterology and Hepatology, Maastricht UMC, University Medical Center, Maastricht, The Netherlands.
M L J SmitsDepartment of Interventional Radiology, UMC Utrecht, University Medical Center, Utrecht, The Netherlands.
F G I van VilsterenDepartment of Gastroenterology and Hepatology, UMC Groningen, University Medical Center, Groningen, The Netherlands.
R P VoermansDepartment of Gastroenterology and Hepatology, Amsterdam University Medical center, University of Amsterdam, Amsterdam, The Netherlands.
I A J ZijlstraDepartment of Interventional Radiology, Amsterdam University Medical center, University of Amsterdam, Amsterdam, The Netherlands.
L M J W van DrielDepartment of Gastroenterology and Hepatology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.
B Groot KoerkampDepartment of Surgery, Erasmus MC Cancer Institute, Rotterdam, The Netherlands. b.grootkoerkamp@erasmusmc.nl.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients 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.

methodsThis 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 registrationNetherlands Trial Register (NL-OMON53463), registered on May 12, 2023, and Clinicaltrials.gov (NCT06671418), registered on November 1, 2024.

Indexed as

Bile Duct NeoplasmsCholestasisDrainageKlatskin TumorStentsAgedAmpulla of VaterFemaleHumansMaleMulticenter Studies as TopicRandomized Controlled Trials as TopicEndoscopic biliary drainageMajor complicationsMalignant hilar biliary obstructionOverall survivalPrimary percutaneous stentingRandomized controlled trial

Identifiers

PMID40346549
PMCPMC12063260

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.