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Study Protocol

The comparative study on axial and coronal CT images using maximum intensity projection for evaluating urinary calculus - a study protocol

[version 1; peer review: 1 not approved]
PUBLISHED 08 Aug 2023
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This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Urinary calculus is a medical condition characterized by the formation of hard deposits in the urinary tract. It is also known as kidney stones and can cause severe pain and discomfort. The most common type of urinary calculus is composed of calcium, but it can be made of other substances such as uric acid or struvite. Risk factors for developing urinary calculus include dehydration, family history, certain medical conditions, and certain medications. Urinary calculi are a common condition that can cause significant discomfort and morbidity in affected individuals. CT imaging is the gold standard technique that helps diagnose urinary calculi. During the examination, axial and coronal images are commonly used. However, the optimal imaging approach has not been clearly defined. The study will include patients with suspected urinary calculi who undergo CT imaging at a single institution. Both axial and coronal images will be reconstructed using M.I.P. The primary outcome measure will be the sensitivity and specificity of the two imaging approaches for detecting urinary calculi. Secondary outcome measures will include the time required for image reconstruction, the radiation exposure associated with each approach, and the subjective preference of the radiologists for one approach over the other. The study is expected to provide valuable information on the optimal imaging approach for evaluating urinary calculi. If one approach is superior, it could lead to a more efficient and effective diagnosis and treatment of this common condition. Additionally, the study will provide data on the radiation exposure associated with each approach, which could inform clinical decision-making and improve patient safety. In this study, the protocol aims to compare the diagnostic performance of axial and coronal C.T. images using maximum intensity projection (MIP) for the evaluation of urinary calculi.

Keywords

Maximum intensity projection (M.I.P.), Urinary calculus, urinary tract, dehydration, image reconstruction, Axial and coronal projections.

Introduction

The Renal Calculi or kidney stones are crystal aggregates within the kidney. Nephrolithiasis is a Greek word. Nephrosis means “kidney”, and lithos means “stone”. It refers to kidneys having stones or calculi in the collecting system. Kidney stones (or) Nephrolithiasis exclusively refers to the presence of calculi (or) stones in the kidneys.1 Renal stones continue to be a prevalent issue, impacting around 10% of individuals at some stage. The occurrence of kidney stones has risen in recent years, although this could be partially attributed to enhanced identification methods.2

For patients who are complaining of acute flank pain and feeling of urolithiasis, unenhanced C.T. is the imaging modality of choice. However, not every patient in this situation has stone illness; others have a different diagnosis for their acute pain, such as diverticulitis, appendicitis, or even pancreatitis.3

Contrary to urolithiasis, contrast-enhanced C.T. (C.E.C.T.) is a better tool for evaluating these entities. It can be challenging to clinically distinguish between these conditions and stone disease, and some patients may need clarification on whether a C.T. scan should be done with or without contrast. Additionally, pyelonephritis and renal abscess, which could mimic or worsen symptomatic urolithiasis, are challenging to detect on unenhanced CT.4

Few studies have specifically looked at the phenomena that have been Theorized to decrease the sensitivity of C.T. for identifying renal stones.

Maximal-intensity projection (M.I.P.) techniques generate a two-dimensional image by projecting a line (or search ray) through a dataset in a given volume, highlighting the voxel with the highest attenuation value. M.I.P. is commonly used in C.T. angiography for evaluation and display purposes.5

In our study, we explored the effectiveness of coronal M.I.P. reformations in detecting and measuring the Hounsfield density of urinary tract stones. We hypothesized that the improved visibility of stones on M.I.P. images would enhance the detection of urinary tract stones compared to regular axial and coronal reformats. Additionally, since M.I.P.s eliminate partial volume-averaging effects, density measurements may be more precise.6

The purpose of the study is to identify which CT Projection (Axial, Coronal M.I.P.) is best for the Detection of Renal stones; the current study was to compare the detection rate and size measurements of Renal calculi on Axial And coronal MIP images.

Protocol

Ethical statement

The ethical statement indicates that the study protocol on the comparative evaluation of urinary calculus has received approval from the Institutional Ethics Committee at D.M.I.H.E.R. (DU), Warda. The study protocol has been assigned the IEC number DMIHER (DU)/IEC/2023/588, confirming its compliance with ethical standards, The study will include 120 patients, and all participants will be requested to provide written informed consent. The statement provides reassurance that the study will be conducted with due consideration for ethical principles.

Study design and participants

The present study constitutes a prospective comparative investigation aimed at assessing the efficacy of Normal Coronal and axial projections vs coronal and axial projections using maximum intensity projection (M.I.P.) in the assessment of urinary calculus. One hundred twenty patients with established urinary calculus will be randomly selected. The primary objective of this investigation is to discern and compare the diagnostic accuracy of M.I.P. in the detection of urinary calculi using these two distinct imaging planes. Additionally, the study endeavours to evaluate the sensitivity of urinary calculus by determining its size, location, and composition.

In order to be considered for inclusion in the study, participants need to satisfy the following requirements:

  • The study will enrol patients referred to Acharya Vinoba Bhave Rural Hospital for urinary calculus evaluation

  • Only patients referred to the radiology department for C.T. Abdomen or KUB imaging will be considered for enrolment

  • Participants should be 18 years or older to be eligible for inclusion in the study

  • Written informed consent will be obtained from all prospective participants prior to enrolment, in adherence with ethical principles

The following criteria must be met by potential participants in order to be excluded from the study:

  • the presence of contraindications for C.T. imaging, such as pregnancy,

  • renal impairment,

  • inability to provide informed consent,

  • participation in other clinical trials within the last three months.

Rationale: This study examined whether axial or coronal maximum-intensity-projection (M.I.P.) reformations enhance renal stone identification in computer tomography by determining the sensitivity of thin axial and coronal M.I.P. images for the diagnosis of renal stones.

Aim: This study’s objective is to assess the efficacy of computed tomography in axial and coronal renal stone identification.

Objectives

  • 1. To identify the morphological structure of stones’ size.

  • 2. To identify the external structure and features of the renal bladder

  • 3. To identify the Renal calculi in the urinary tract

  • 4. To identify the location of the renal stone in the abdomen

Sample size

One hundred twenty participants (n=120) were enrolled in the study, consisting of individuals aged 18 years and above who were visiting the radiology department for Abdo-Pelvic CT scans.

Sampling procedure and formula used:

n=z2p1Pd2

Z2 is the level of Significance at 5%, i.e. 95%

Confidence interval =1.96

P = Expected prevalence or proportion = 2.8% = 0.028

D=precision (if the precision is 3%, then d = 0.03)

n=1.962×0.02810.0280.032

n = 120

Study Reference: Sajal Sayeed

Formula reference: Daniels’s formula

Software used: SPSS 27.0 version

Methodology

Over two years, we plan to recruit 120 patients over the age of 18 who have been referred to A.B.V.R.H. hospital. The study will focus on the visible anatomy and specific information regarding the size, shape, and location of the urinary stones and the techniques used to capture the images.

During the study, we will compare the calculus size measurements in three planes: A.P. × TRANS × CRANIOCAUDAL between the C.T. Axial, Coronal, and CT M.I.P. Axial and Coronal images, with a focus on stones measuring 4 mm, 6 mm, and 8 mm with your innovative study, you hope to provide valuable insights into the efficacy of using maximum intensity projection for the evaluation of urinary calculus, potentially paving the way for improved diagnostic and treatment options for patients.

Setting

Department of Radio Diagnosis, Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of Higher Education & Research. Relevant dates, including periods of recruitment: October 2022 – October 2024.

Sample size selection

All the patients presented to the Department of Radio Diagnosis, Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of Higher Education & Research for a CT Abdomen and Pelvis scan will be considered.

Outcome: Overall, the study protocol provides a structured approach for investigating the comparative efficacy of axial and coronal C.T. images using maximum intensity projection to evaluate urinary calculus. The study’s real findings may offer fresh perspectives on the identification and management of urinary calculi. They could aid in the creation of better imaging methods for this illness.

Data analysis: The study will be conducted once the final report has been finished.

Type of study: Closs sectional study

Duration of study: 2 years

Place of study: Datta Maghe Institute of higher education and Research Sawangi Wardha

Steps involved

  • 1. The study will use a 16-slice S.O.M.A.T.O.M. Machine CT scanner to perform Abdomen/KUB scans.

  • 2. 120 patients who are 18 years or older and referred to A.B.V.R.H. hospital will be considered.

  • 3. The technique of reconstructed soft-tissue window imaging will be used for the C.T. scan.

  • 4. The reconstructed Axial, Coronal images, and Axial, Coronal M.I.P. images of the abdomen and KUB will be used to compare the findings.

  • 5. The study will describe visible anatomies, such as size, shape, and location, as well as specific information about identified stones and imaging techniques used to capture the images.

  • 6. The study will take place over a two-year period, during which the patients will receive counseling.

  • 7. The calculus size measurement will be compared in 3 planes (A.P. × TRANS × CRANIOCAUDAL) between C.T. Axial, Coronal, and CT M.I.P. Axial and Coronal images.

  • 8. The size of the calculi to be measured will be 4 mm, 6 mm, and 8 mm.

Discussion

The results of the study suggest that thin images obtained from contrast-enhanced C.T. (CECT) during the portal venous phase are highly effective in detecting renal stones measuring 2 mm or larger. However, for patients experiencing acute flank pain with suspected renal stone disease, unenhanced C.T. is still the recommended imaging test. Traditionally, C.E.C.T. has been considered inadequate for detecting renal stones and is not recommended in such cases. Flank pain can be caused by conditions other than urolithiasis, and various renal disorders can present similar symptoms.7 This poses a challenge in selecting the most suitable imaging protocol when evaluating patients suspected of having urolithiasis along with other conditions like appendicitis or diverticulitis.

If contrast material is used to optimize the evaluation, it is important to be aware of the sensitivity of C.E.C.T. in detecting renal stones.8 The reduced sensitivity of C.E.C.T. in this regard is attributed to the enhanced appearance of the kidneys, which diminishes the contrast between the stones and the renal parenchyma. Recent studies have reported varying sensitivities in detecting renal stones with C.E.C.T.9 One study found an overall sensitivity of 81% for detecting renal stones, with higher sensitivity for larger stones. Another study focusing on arterial phase CT detected 75% of renal calculi and all stones larger than 5 mm. The differences in sensitivities could be due to variations in slice thickness, as thinner slices have been shown to enhance renal stone detection on unenhanced CT.10

Thin images from portal venous phase C.E.C.T. demonstrate high sensitivity in detecting renal stones measuring 2 mm or larger. However, for patients with acute flank pain and suspected renal stone disease, unenhanced CT remains the recommended imaging test. C.E.C.T. has historically been deemed inadequate for detecting renal stones and is not recommended for this purpose.11 It is important to consider the challenges in accurately diagnosing renal stones, as other conditions can mimic urolithiasis symptoms. The choice of imaging protocol should be carefully considered, taking into account potential alternative conditions and the sensitivity of C.E.C.T. in detecting renal stones. Thinner image slices have shown improved detection of renal stones on unenhanced CT.12

Study status

Ongoing; expected to complete before October 2024

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Asrar ul haq Andrabi S, Tivaskar S, Luharia A et al. The comparative study on axial and coronal CT images using maximum intensity projection for evaluating urinary calculus - a study protocol [version 1; peer review: 1 not approved]. F1000Research 2023, 12:952 (https://doi.org/10.12688/f1000research.138981.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Open Peer Review

Current Reviewer Status: ?
Key to Reviewer Statuses VIEW
ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
Version 1
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PUBLISHED 08 Aug 2023
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Reviewer Report 05 Oct 2023
Elanchezhian Somasundaram, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA 
Not Approved
VIEWS 7
  1. The writing is not clear and confusing to read.
     
  2. The objectives are also not clear. What is the clinical benefit of evaluating a MIP image? How is this going to reduce the
... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Somasundaram E. Reviewer Report For: The comparative study on axial and coronal CT images using maximum intensity projection for evaluating urinary calculus - a study protocol [version 1; peer review: 1 not approved]. F1000Research 2023, 12:952 (https://doi.org/10.5256/f1000research.152218.r206211)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
  • Author Response 13 Apr 2024
    syed asrar, Department of Radiology, Datta Meghe Institute of Higher Education and Research, Wardha, 140002, India
    13 Apr 2024
    Author Response
    Sir, I hold your opinions in high regard, and I genuinely appreciate your insights. Sir, may I kindly inquire where you find aspects of my study confusing? Your guidance is ... Continue reading
COMMENTS ON THIS REPORT
  • Author Response 13 Apr 2024
    syed asrar, Department of Radiology, Datta Meghe Institute of Higher Education and Research, Wardha, 140002, India
    13 Apr 2024
    Author Response
    Sir, I hold your opinions in high regard, and I genuinely appreciate your insights. Sir, may I kindly inquire where you find aspects of my study confusing? Your guidance is ... Continue reading

Comments on this article Comments (0)

Version 1
VERSION 1 PUBLISHED 08 Aug 2023
Comment
Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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