Evidence map›Paper›PMID 39311927›Full record

Trial reportInternational journal of surgery (London, England)2025

Radiation-emitting metallic stent for unresectable Bismuth type III or IV perihilar cholangiocarcinoma: a multicenter randomized trial.

Qi Chen, Nai-Jian Ge, Yu-Liang Li, Ming Huang, Wen-Hui Li, Dong Lu, Ning Wei, Peng-Hua Lv, Jian-Fei Tu, Cheng-Jian He and 12 more

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of surgery (London, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Review
  3. 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

22 authors.

Qi ChenCenter of Interventional Radiology and Vascular Surgery, Department of Radiology, Zhongda Hospital, Medical School, Southeast University, Nanjing.
Nai-Jian GeDepartment of Interventional Radiology, Eastern Hospital of Hepatobiliary Surgery, Navy Medical University (Second Military Medical University), Shanghai.
Yu-Liang LiDepartment of Interventional Medicine, The Second Hospital of Shandong University, Jinan.
Ming HuangDepartment of Minimally Invasive Interventional Therapy, Yunnan Tumor Hospital, The Third Affiliated Hospital of Kunming Medical University, Kunming.
Wen-Hui LiDepartment of Interventional Radiology, Yancheng Third People's Hospital, Yancheng.
Dong LuDivision of Life Sciences and Medicine, University of Science and Technology of China, Hefei; Department of Radiology, University of Science and Technology of China, Hefei; The First Affiliated Hospital of USTC, Anhui Provincial Hospital.
Ning WeiDepartment of Interventional Radiology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China.
Peng-Hua LvDepartment of Interventional Radiology, Subei People's Hospital of Jiangsu Province (Clinical Medical College of Yangzhou University), Yangzhou, Jiangsu Province.
Jian-Fei TuDepartment of Interventional Radiology, Lishui Hospital of Zhejiang University, The Fifth Affiliated Hospital of Wenzhou Medical University, Lishui Central Hospital, Lishui.
Cheng-Jian HeDepartment of Interventional Radiology, Eastern Hospital of Hepatobiliary Surgery, Navy Medical University (Second Military Medical University), Shanghai.
Wu-Jie WangDepartment of Interventional Medicine, The Second Hospital of Shandong University, Jinan.
Rong DingDepartment of Minimally Invasive Interventional Therapy, Yunnan Tumor Hospital, The Third Affiliated Hospital of Kunming Medical University, Kunming.
Bo PengDepartment of Minimally Invasive Interventional Therapy, Yunnan Tumor Hospital, The Third Affiliated Hospital of Kunming Medical University, Kunming.
Xue-Jun WangDepartment of Interventional Radiology, Yancheng Third People's Hospital, Yancheng.
Fu-An WangDepartment of Interventional Radiology, Subei People's Hospital of Jiangsu Province (Clinical Medical College of Yangzhou University), Yangzhou, Jiangsu Province.
Guang-Yu ZhuCenter of Interventional Radiology and Vascular Surgery, Department of Radiology, Zhongda Hospital, Medical School, Southeast University, Nanjing.
Yong WangCenter of Interventional Radiology and Vascular Surgery, Department of Radiology, Zhongda Hospital, Medical School, Southeast University, Nanjing.
Li ChenCenter of Interventional Radiology and Vascular Surgery, Department of Radiology, Zhongda Hospital, Medical School, Southeast University, Nanjing.
Jie MinDepartment of Epidemiology and Biostatistics, School of Public Health, Southeast University, Nanjing, People's Republic of China.
Jin-He GuoCenter of Interventional Radiology and Vascular Surgery, Department of Radiology, Zhongda Hospital, Medical School, Southeast University, Nanjing.
Gao-Jun TengCenter of Interventional Radiology and Vascular Surgery, Department of Radiology, Zhongda Hospital, Medical School, Southeast University, Nanjing.
Jian LuCenter of Interventional Radiology and Vascular Surgery, Department of Radiology, Zhongda Hospital, Medical School, Southeast University, Nanjing.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsSelf-expandable metallic stents (SEMSs) have been recommended for patients with unresectable malignant biliary obstruction, while radiation-emitting metallic stents (REMSs) loaded with 125 I seeds have recently been approved to provide longer patency and overall survival in malignant biliary tract obstruction. This trial is to evaluate the efficacy and safety of REMS plus hepatic arterial infusion chemotherapy (REMS-HAIC) versus SEMS plus HAIC (SEMS-HAIC) for unresectable perihilar cholangiocarcinoma (pCCA). MATERIALS AND

methodsThis multicenter randomized controlled trial recruited patients with unresectable Bismuth type III or IV pCCA between March 2021 and January 2023. Patients were randomly assigned (1:1 ratio) to receive either REMS-HAIC or SEMS-HAIC using permuted block randomization, with a block size of six. The primary endpoint was overall survival (OS). The secondary endpoints were time to symptomatic progression (TTSP), stent patency, relief of jaundice, quality of life, and safety.

resultsA total of 126 patients were included in the intent-to-treat population, with 63 in each group. The median OS was 10.2 months versus 6.7 months ( P =0.002). The median TTSP was 8.6 months versus 5.4 months ( P =0.003). The median stent patency was longer in the REMS-HAIC group than in the SEMS-HAIC group ( P =0.001). The REMS-HAIC group showed better improvement in physical functioning scale ( P <0.05) and fatigue symptoms ( P <0.05) when compared to the SEMS-HAIC group. No significant differences were observed in relief of jaundice (85.7% vs. 84.1%; P =0.803) or the incidence of grade 3 or 4 adverse events (9.8% vs. 11.9%; P =0.721).

conclusionREMS plus HAIC showed better OS, TTSP, and stent patency compared with SEMS plus HAIC in patients with unresectable Bismuth type III or IV pCCA with an acceptable safety profile.

Indexed as

Bile Duct NeoplasmsKlatskin TumorSelf Expandable Metallic StentsStentsAgedFemaleHumansMaleMiddle AgedQuality of LifeTreatment Outcome

Identifiers

PMID39311927
PMCPMC11745636

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Registered trials

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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.