Evidence map›Paper›PMID 39240508›Full record

Trial reportIndian journal of gastroenterology : official journal of the Indian Society of Gastroenterology2025

Adjuvant endobiliary radio-frequency ablation combined with self-expandable biliary metal stents for unresectable malignant hilar strictures: A pragmatic comparative study.

Nitin Jagtap, C Sai Kumar, Sundeep Lakhtakia, Mohan Ramchandani, Sana Fathima Memon, Shujaath Asif, Rakesh Kalapala, Zaheer Nabi, Jahangeer Basha, Rajesh Gupta and 2 more

Registry-linked trialAbstract readComparative StudyPragmatic Clinical Trial
PubMed Publisher
In one paragraph

Trial report in Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05320328 (SAFETY AND EFFICACY OF INTRA DUCTAL RADIO FREQUENCY ABLATION IN UNRESECTABLE MALIGNANT BILIARY OBSTRUCTION), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT05320328 unknown statusnot on this map

Safety and efficacy of intra ductal radio frequency ablation in unresectable malignant biliary obstruction: prospective observational study

TypeobservationalSponsorAsian Institute of Gastroenterology, IndiaRan2021 to 2022Enrolled50ConditionsBile Duct Neoplasms, Gall Bladder CarcinomaArmsRadio frequency ablation
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Advanced Endoscopy: Future Training Perspectives and Tracks.Current gastroenterology reports · 2025
    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

12 authors.

Nitin JagtapDepartment of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, 500 082, India. docnits13@gmail.com.ORCID 0000-0002-3469-0164
C Sai KumarDepartment of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, 500 082, India.
Sundeep LakhtakiaDepartment of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, 500 082, India.
Mohan RamchandaniDepartment of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, 500 082, India.
Sana Fathima MemonDepartment of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, 500 082, India.
Shujaath AsifDepartment of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, 500 082, India.
Rakesh KalapalaDepartment of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, 500 082, India.
Zaheer NabiDepartment of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, 500 082, India.
Jahangeer BashaDepartment of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, 500 082, India.
Rajesh GuptaDepartment of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, 500 082, India.
Manu TandanDepartment of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, 500 082, India.
D Nageshwar ReddyDepartment of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, 500 082, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe role of endo-biliary radio-frequency ablation (EB-RFA) in treating malignant biliary strictures remains a subject of controversy. This study aims to assess the efficacy and safety of EB-RFA in conjunction with self-expandable metal stents (SEMS) compared to SEMS alone.

methodsThis single-center prospective pragmatic comparative study, conducted between June 2021 and November 2022, involved 23 patients undergoing EB-RFA plus SEMS and 48 patients undergoing SEMS for unresectable malignant hilar obstruction. The study evaluated overall survival, stent patency and adverse events.

resultsSeventy-one patients (mean age [SD], 57.8 [11.2] years; 73.2% men) were enrolled. The clinical success rates did not significantly differ between the two groups (78.3% in EB-RFA and 66.6% in SEMS; p 0.316). The median (95% CI) overall survival was 155 (79.87-230.13) days in the EB-RFA group, contrasting with 86.0 (78.06-123.94) days in the SEMS group (p 0.020). The presence of carcinoma gallbladder (p 0.035; HR 0.55; 95% CI 0.32-0.96) and EB-RFA (p 0.047; HR 1.88; 95% CI 1.01-3.49) independently predicted overall survival. Median (95% CI) stent patency was 143.0 (95% CI, 61.61-224.39) days in the EB-RFA group compared to 78.0 (95% CI, 32.74-123.26) days in the SEMS group (p 0.019). The presence of carcinoma gallbladder (p 0.046, HR 0.60; 95% CI, 0.36-0.99), EB-RFA (p 0.023; HR 1.92; 95% CI, 1.10-3.36) and chemotherapy (p 0.017, HR 1.91; 95% CI, 1.12-3.26) independently predicted longer stent patency. There was no difference in procedure-related adverse events in both groups.

conclusionEB-RFA with SEMS placement proves to be a safe and effective technique for palliative biliary decompression in patients with malignant biliary strictures, demonstrating superior overall survival and stent patency compared to SEMS alone. Further confirmation through multi-center trials is warranted. CLINICAL

trial registrationClinicalTrials.gov (ID: NCT05320328).

Indexed as

Bile Duct NeoplasmsCholestasisRadiofrequency AblationSelf Expandable Metallic StentsAdultAgedCombined Modality TherapyConstriction, PathologicFemaleHumansMaleMiddle AgedProspective StudiesTreatment OutcomeCholangiocarcinoma hilar strictureMetal stent radiofrequency ablationSurvival

Identifiers

PMID39240508

What OpenQuestion holds

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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.