Trial reportSurgical endoscopy2022
Stent placement above the sphincter of Oddi is a useful option for patients with inoperable malignant hilar biliary obstruction.
Trial report in Surgical endoscopy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled 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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 21 citations in OpenAlex.
- Safety and efficacy of biliary suprapapillary metal and plastic stents in malignant biliary obstruction: a systematic review and meta-analysis.Surgical endoscopy · 2024Pooled it
- Meta-analysis on clinical outcomes of suprapapillary versus transpapillary stent insertion in malignant biliary obstruction.Surgical endoscopy · 2023Pooled it
- Above- Versus Across-The-Papilla Plastic Stent Placement for Malignant Hilar Biliary Obstruction in Unresectable Biliary Tract Cancer: A Multicentre IPTW Analysis.Journal of hepato-biliary-pancreatic sciences · 2026Observational
- Outcomes of Suprapapillary Versus Transpapillary Biliary Stent Placement for Palliation of Malignant Hilar Biliary Obstruction.Cardiovascular and interventional radiology · 2026Article
- Article
- Impact of Sphincterotomy on Suprapapillary Inside Stent Patency in Unresectable Malignant Hilar Biliary Obstruction: A Multicenter Cohort Study.Endoscopy international open · 2026Article
- Endoscopic Stenting for Unresectable Malignant Hilar Biliary Obstruction: Where Do We Stand Today? A Narrative Review.Current oncology (Toronto, Ont.) · 2025Review
- Article
- Efficacy of a Novel Dual-Layer Plastic Stents for Malignant Biliary Obstruction.Journal of clinical medicine · 2025Article
- Updates on Endoscopic Stenting for Unresectable Malignant Hilar Biliary Obstruction.Journal of clinical medicine · 2024Article
- A Novel Method of Calculating the Drained Liver Volume Using a 3D Volume Analyzer for Biliary Drainage of Unresectable Malignant Hilar Biliary Obstruction.Digestive diseases and sciences · 2024Review
- The "coupler" technique for endoscopic removal of a threaded inside stent that migrated above tight hilar strictures.Endoscopy · 2023Article
- Endoscopic gallbladder inside-stenting combined with aspirated lavage for calculous cholecystitis in poor surgical candidates: a prospective pilot study.Scientific reports · 2023Article
- Different percutaneous transhepatic biliary stent placements and catheter drainage in the treatment of middle and low malignant biliary obstruction.World journal of gastrointestinal surgery · 2023Article
- Clinical Outcomes of Inside Stents and Conventional Plastic Stents as Bridge-to-Surgery Options for Malignant Hilar Biliary Obstruction.Digestive diseases and sciences · 2023Review
- Optimal endoscopic drainage strategy for unresectable malignant hilar biliary obstruction.Clinical endoscopy · 2023Review
- The Feasibility of Whole-Liver Drainage with a Novel 8 mm Fully Covered Self-Expandable Metal Stent Possessing an Ultra-Slim Introducer for Malignant Hilar Biliary Obstructions.Journal of clinical medicine · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
aimsEndoscopic biliary drainage (EBD) is essential for the management of malignant hilar biliary obstruction (MHBO). We prospectively evaluated the efficacy and safety of "inside-stent" therapy, where a plastic stent is placed above the sphincter of Oddi without endoscopic sphincterotomy, in patients with inoperable MHBO.
methodsThis study was a multicenter, single-blinded, randomized controlled trial at three centers. Patients with inoperable MHBO were enrolled in this study, and randomly assigned to receive an inside-stent or conventional-stent therapy. The primary endpoint was cumulative stent patency of the initial stent. The secondary endpoints were second stent patency, technical and clinical success rate, adverse events, re-intervention rate, and overall patient survival.
resultsForty-three patients were randomly assigned to the inside-stent group (n = 21) or the conventional-stent group (n = 22). The median cumulative stent patency of the initial stent was 123 days in the inside-stent group and 51 days in the conventional-stent group (P = .031). For patients with the initial stent dysfunction in the conventional-stent group, the inside-stent was placed as a second stent, and its patency was significantly longer than that of the initial stent (P = .0001). The technical and clinical success rate, re-intervention rate, second stent patency, adverse events, and survival probability did not differ between the groups.
conclusionsInside-stent therapy appears to be useful not only as an initial stent but also as a second stent for patients with inoperable MHBO. TRIAL REGISTRATION NUMBER: UMIN000004587.
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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.