Evidence map›Paper›PMID 37171588›Full record

Trial reportWorld journal of surgery2023

Evaluation of Dual Dye Technique for Sentinel Lymph Node Biopsy in Breast Cancer: Two-Arm Open-Label Parallel Design Non-Inferiority Randomized Controlled Trial.

Suhani, Utkarsh Kumar, V Seenu, Jitendar Sodhi, Mohit Joshi, H K Bhattacharjee, M A Khan, Sandeep Mathur, Rakesh Kumar, Rajinder Parshad

Abstract readRandomized Controlled TrialEquivalence Trial
PubMed Publisher
In one paragraph

Trial report in World journal of surgery, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–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

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

SuhaniDepartment of Surgical Disciplines, All India Institute of Medical Sciences, Masjid Moth campus, Ansari Nagar East, New Delhi, India. drsuhani@gmail.com.
Utkarsh KumarDepartment of Surgical Disciplines, All India Institute of Medical Sciences, Masjid Moth campus, Ansari Nagar East, New Delhi, India.
V SeenuDepartment of Surgical Disciplines, All India Institute of Medical Sciences, Masjid Moth campus, Ansari Nagar East, New Delhi, India.
Jitendar SodhiDepartment of Hospital Administration, All India Institute of Medical Sciences, New Delhi, India.
Mohit JoshiDepartment of Surgical Disciplines, All India Institute of Medical Sciences, Masjid Moth campus, Ansari Nagar East, New Delhi, India.
H K BhattacharjeeDepartment of Surgical Disciplines, All India Institute of Medical Sciences, Masjid Moth campus, Ansari Nagar East, New Delhi, India.
M A KhanDepartment of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.
Sandeep MathurDepartment of Pathology, All India Institute of Medical Sciences, New Delhi, India.
Rakesh KumarDepartment of Nuclear Medicine, All India Institute of Medical Sciences, New Delhi, India.
Rajinder ParshadDepartment of Surgical Disciplines, All India Institute of Medical Sciences, Masjid Moth campus, Ansari Nagar East, New Delhi, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRadioisotope and blue dye are standard agents for performing sentinel lymph node (SLN) biopsy in breast cancer. The paucity of nuclear medicine facility poses logistic challenge. This study evaluated performance of radioisotope & methylene blue (MB) with indocyanine green (ICG) and MB for SLNB. PATIENTS AND

methodsThis randomized controlled trial was conducted from December 2019 to July 2022 comparing SLN identification proportions of radioisotope-blue dye [Group A] with dual dye (MB + ICG; Group B]. Secondary objective included time required and cost effectiveness of performing SLNB. Sample size of 70 (35 in each arm) was calculated. Upfront operable node negative early breast cancer was included in the study. Clinico-demographic data, number & type of SLN, time taken were noted. Cost analysis was done including the equipment, manpower & consumables. Chi-square/Fisher exact test was used to compare proportion between two groups. p value of less than 0.05 was considered to represent statistical significance.

resultsSeventy patients randomized to either group were similar in clinico-demographic and tumor characteristics. SLN identification rate (IR) was 91.43% in group A and 100% in group B. Overall IR of MB, radioisotope and ICG were 91.43%, 91.43% and 100%, respectively. Mean number of SLNs identified were 3 in group A and 4 in group B. Median time required for SLNB was 12 min and 14 min in either group, respectively. Cost of performing SLNB was higher in Group B.

conclusionSLNB using dual dye is non-inferior to radioisotope-blue dye in upfront operable early breast cancer. Trial registration number Clinical Trial registry India CTRI/2020/02/023503.

Indexed as

Breast NeoplasmsSentinel Lymph Node BiopsyColoring AgentsFemaleHumansIndocyanine GreenLymph NodesRadionuclide ImagingColoring AgentsIndocyanine Green

Identifiers

PMID37171588

What OpenQuestion holds

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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.