Evidence map›Paper›PMID 27864713›Full record

Trial reportSurgical endoscopy2017

A prospective randomized study for efficacy of an uncovered double bare metal stent compared to a single bare metal stent in malignant biliary obstruction.

Hyun Jik Lee, Moon Jae Chung, Jeong Yup Park, Seung Woo Park, Chung Mo Nam, Si Young Song, Seungmin Bang

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Surgical endoscopy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01869894 (A Prospective Randomized Study for Efficacy of Uncovered Double Bare Metallic Stent Compared to Uncovered Single Bare Metallic Stent in Malignant Biliary Obstruction), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
0.8field-weighted citation impact, top 23% of its field
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.

NCT01869894 nacompletednot on this map

A Prospective Randomized Study for Efficacy of Uncovered Double Bare Metallic Stent Compared to Uncovered Single Bare Metallic Stent in Malignant Biliary Obstruction

TypeinterventionalSponsorYonsei UniversityRan2013 to 2014Enrolled73ConditionsMalignant Biliary ObstructionArmsmetallic biliary stent insertion (double bare - S&G Biotech.), metallic biliary stent insertion (single bare - S&G Biotech.), metallic biliary stent insertion (single bare - Taewoong Medical.)
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 13 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Novel 7-mm-diameter double bare metal stent for endoscopic side-by-side stent placement in malignant hilar biliary obstruction.VideoGIE : an official video journal of the American Society for Gastrointestinal Endoscopy · 2020
    Article
  9. Percutaneous transpapillary biliary stent placement for distal malignant biliary obstruction: Outcomes and survival analysis.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2019
    Article
  10. Observational
  11. Article
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

7 authors at 1 institution in 1 country.

Hyun Jik LeeDepartment of Internal Medicine, Institute of Gastroenterology, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, Korea.
Moon Jae ChungDepartment of Internal Medicine, Institute of Gastroenterology, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, Korea.
Jeong Yup ParkDepartment of Internal Medicine, Institute of Gastroenterology, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, Korea.
Seung Woo ParkDepartment of Internal Medicine, Institute of Gastroenterology, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, Korea.
Chung Mo NamDepartment of Biostatistics, Yonsei University College of Medicine, Seoul, Korea.
Si Young SongDepartment of Internal Medicine, Institute of Gastroenterology, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, Korea.
Seungmin BangDepartment of Internal Medicine, Institute of Gastroenterology, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, Korea. bang7028@yuhs.ac.
Yonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsA biliary self-expandable metal stent (SEMS) is commonly used to relieve malignant biliary obstruction. The aim of this study was to compare the efficacy of a conventional uncovered SEMS with that of a newly developed uncovered double bare metal stent in reducing the risk of stent occlusion caused by tumor ingrowth. PATIENTS AND

methodsWe performed a prospective, open-labeled, randomized trial in 71 patients at Severance Hospital, Yonsei University College of Medicine from June 2013 to June 2014. Patients with inoperable malignant biliary obstruction were included and randomized to receive an uncovered single bare metal stent (SBSs; S&G Biotech Inc.), an uncovered single bare metal stent (SBSt; Taewoong Medical), or an uncovered double bare metal stent (DBS; S&G Biotech Inc.).

resultsThe mean age was 66.6 years (range, 35-83), and 42 (59.2%) were male. The mean duration of stent patency was 212 days (±152) in the DBS group (n = 24) compared with 124 days (±98) in the SBSs group (n = 23; P = 0.022 for noninferiority) and 116 days (±79) in the SBSt group (n = 24; P = 0.010 for noninferiority). There were no differences in the incidences of early and delayed complications or migration.

conclusionsThe newly developed DBS is noninferior to the conventional uncovered SEMSs on duration of stent patency and tumor ingrowth occurred less frequently in the DBS group. This might decrease the need for reintervention and offer a better quality of life. The trial is registered with Clinicaltrials.gov no: NCT01869894.

Indexed as

StentsAdultAgedAged, 80 and overCholestasisEquipment DesignFemaleHumansMaleMiddle AgedPancreatic NeoplasmsPostoperative ComplicationsProspective StudiesTreatment OutcomeERCPExtrahepatic biliary obstructionMalignant bile duct obstructionMetal stentUncovered metal stent

Identifiers

PMID27864713
OpenAlexW2551934069

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.