Trial reportAnnals of surgical oncology2026
Preoperative Biliary Drainage with Metal Stent Versus Early Surgery in Patients with Pancreatic Cancer: A Randomized Clinical Trial.
Trial report in Annals of surgical oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01774019 (Randomized Multi-Center Study Comparing No Drainage to Preoperative Biliary Drainage Using Metal Stents in Patients With Resectable Pancreatic or Periampullary Cancer), which is not on this map. Cited by 1 paper.
What it found
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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.
Randomized Multi-Center Study Comparing No Drainage to Preoperative Biliary Drainage Using Metal Stents in Patients With Resectable Pancreatic or Periampullary Cancer
Who cites it
1 citing paper in PubMed.
- ASO Author Reflections: Preoperative Biliary Drainage-A Controversial Intervention with a Complicated Past.Annals of surgical oncology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAmong patients with pancreatic cancer and biliary obstruction planned for pancreaticoduodenectomy, preoperative biliary drainage (PBD) may be considered during surgical delays. Higher complication rates have been reported for PBD using plastic stents versus early surgery. PBD with a self-expanding metal stent (SEMS) has not been compared with early surgery in a randomized controlled trial (RCT). PATIENTS AND
methodsWe conducted a noninferiority RCT comparing PBD using a SEMS versus early surgery at 11 centers in 9 countries. We enrolled patients with resectable pancreatic or periampullary cancer and serum total bilirubin level ≥ 5.8 mg/dL, scheduled for primary resection. Primary endpoint was the proportion of patients reporting ≥ 1 serious adverse event (SAE) 120 days post-randomization. Secondary endpoints included rate of SEMS insertion, rate of curative-intent resection, and all-cause mortality.
resultsAmong 284 patients, 144 were randomized to PBD and 140 to early surgery. In the modified intention-to-treat primary endpoint analysis, ≥ 1 SAE(s) occurred in 29.0% (40/138) in the PBD group and 26.5% (36/136) in the early surgery group (between-group difference, 2.5%; one-sided upper 95% confidence limit, 11.7%; P = 0.011 for noninferiority). Among 144 PBD patients, 140 (97.2%) received a SEMS; 119 (82.6%) underwent surgery with curative intent. Among 140 early surgery patients, 14 (10.0%) underwent ERCP and drainage; 130 (92.9%) underwent surgery with curative intent in 115 (88.5%). During follow-up, 7.9% (11/138) in the PBD group and 8.0% (11/136) in the early surgery group died.
conclusionSafety following PBD using SEMS was noninferior to early surgery for pancreatic or periampullary cancer. CLINICALTRIALS: gov, no. NCT01774019.
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