Evidence map›Paper›PMID 27770248›Full record

Trial reportInternational journal of colorectal disease2017

A trial of radiofrequency ablation for anal intraepithelial neoplasia.

Robert N Goldstone, Shirin R Hasan, Steven Drury, Teresa M Darragh, Annemieke van Zante, Stephen E Goldstone

Abstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in International journal of colorectal disease, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
1.9field-weighted citation impact, top 14% 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.

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

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 22 citations in OpenAlex.

  1. Pooled it
  2. German-Austrian guideline on screening for anal dysplasia and anal carcinoma in people living with HIV.Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG · 2025
    Guideline
  3. Review
  4. Review
  5. Article
  6. Article
  7. Working to prevent anal cancer through innovation.Techniques in coloproctology · 2021
    Article
  8. Article
  9. Article
  10. 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

6 authors at 4 institutions in 1 country.

Robert N GoldstoneMassachusetts General Hospital, Boston, MA, USA.
Shirin R HasanMedtronic, Sunnyvale, CA, USA.
Steven DruryMedtronic, New Haven, CT, USA.
Teresa M DarraghDepartments of Pathology and Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, San Francisco, CA, USA.
Annemieke van ZanteDepartment of Pathology, University of California San Francisco, San Francisco, CA, USA.
Stephen E GoldstoneIcahn School of Medicine, Mount Sinai, 420 West 23rd St, New York, NY, 10011, USA. goldstone.stephen@gmail.com.
Medtronic (United States) · USUniversity of California, San Francisco · USIcahn School of Medicine at Mount Sinai · USMassachusetts General Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeRadiofrequency ablation (RFA) effectively treats esophageal high-grade dysplasia, but its efficacy in treating anal canal high-grade squamous intraepithelial lesions (HSILs) is unsubstantiated. This prospective study assessed the safety and efficacy of applying hemi-circumferential RFA to anal canal HSIL.

methodsTwenty-one HIV-negative participants with HSIL occupying ≤ half the anal canal circumference were treated with hemi-circumferential anal canal RFA. Participants were assessed every 3 months for 12 months with high-resolution anoscopy; recurrence in the treatment zone was re-treated with focal RFA.

resultsTwenty-one participants with a mean of 1.7 lesions (range 1-4) enrolled and completed the trial. Six (29 %) participants had recurrent HSIL within the treated hemi-circumference within 1 year. Four participants (19 %) had persistence of an index lesion at 3 months. One (2.9 %) index HSIL persisted again at 12 months. No participants had more than two RFA treatments. KM curve-predicted HSIL-free survival within the treatment zone at 1 year was 76 % (95 % CI 52-89 %). Comparing the first 7 and last 14 participants, the predicted 1-year HSIL-free survivals are 43 % (95 % CI 10-73 %) and 93 % (95 % CI 59-99 %), respectively (p = 0.008), suggesting a learning curve with the treating physician. Multivariable analysis showed decreased recurrence in the last 14 participants (HR 0.02; 95 % CI 0.001-0.63) while increasing BMI increased recurrence (HR 1.43, 95 % CI 1.01-2.01). No participants had device or procedure-related serious adverse events, anal stricture, or heavy bleeding.

conclusionsHemi-circumferential RFA yielded a high rate of anal HSIL eradication in HIV-negative patients at 1 year with minimal adverse events. Lesion persistence was probably related to incomplete initial ablation.

Indexed as

Catheter AblationAdultAgedAnus NeoplasmsCarcinoma in SituDemographyFemaleHumansKaplan-Meier EstimateMaleMiddle AgedMultivariate AnalysisNeoplasm Recurrence, LocalPostoperative PainRisk FactorsTreatment OutcomeAnal cancerHigh-grade squamous intraepithelial lesionRadiofrequency ablation

Identifiers

PMID27770248
OpenAlexW2535501417

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.