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Clinico-radiological Classification of Peritoneal Tuberculosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03927664
Recruitment Status : Completed
First Posted : April 25, 2019
Last Update Posted : August 31, 2020
Sponsor:
Information provided by (Responsible Party):
Vishal Sharma, Postgraduate Institute of Medical Education and Research

Brief Summary:

Traditionally, peritoneal tuberculosis has been classified as wet-ascitic, dry-plastic type and fibrotic -fixed types. there is substantial overlap between these definitions and the clinical implication of the categorisation into the three patterns is unclear.

The clinical presentation will be used to divide participants into 1) Abdominal distension dominant disease or 2) Pain Dominant and/or 3) Obstruction dominant peritoneal tuberculosis. The radiological findings between these groups will be compared if findings on radiology are discriminative of these three patterns of presentation.


Condition or disease Intervention/treatment
Tuberculosis Tuberculosis; Abdomen (Etiology) Tuberculosis, Peritoneal Other: Radiological assessment

Detailed Description:

The study will be conducted as two parts

  1. Derivation group:

    Screening population: Patients with abdominal tuberculosis treated in the gastroenterology unit from Jan 2017-Dec 2018 This will involve a retrospective study where the patients who have been treated for peritoneal tuberculosis and have full records available (as hospital records or Gut-Tuberculosis clinic files) will be included and their clinical details and radiological findings (from CT films or images) will be entered and compared. The radiological findings between these groups will be compared if findings on radiology are discriminative of these three patterns of presentation.

  2. Validation Study: This will include prospective study of patients who have underwent computed tomography for evaluation of abdominal complaints and are eventually diagnosed to have peritoneal tuberculosis. The radiological parameters derived from the derivation group will be tested to predict the clinical presentation.

At the end of the study,the feasibility of a clinico-radiological classification of peritoneal tuberculosis.

The clinical details will be recorded and will include demographic details, diagnostic work-up (confirmed/probable), follow-up and classification into one of the three patterns of presentation

  1. Distension dominant: Presence of abdominal distention or discomfort, Lack of pain
  2. Pain dominant: Patients having associated significant abdominal pain necessitating analgesics or interfering with routine activities
  3. Obstruction dominant; Clear historical and/or radiological evidence of intestinal obstruction like abdominal pain associated with distension and obstipation

Computed tomographic scans/images will be assessed by the two radiologists separately and resolved by consensus The radiologists will not have access to any clinical details The findings will be recorded on a proforma and will include determination of presence and extent of ascites, loculated ascites, peritoneal nodules or masses, omental involvement as nodules or masses, mesenteric adenopathy, masses, abdominal lymphadenopathy, presence of clumped loops, adhesions, abdominal cocoon etc The three groups will be compared for these radiological patterns and a possible correlation between any radiological findings and the clinical presentation will be derived.

The classification derived from the derivation cohort will be tested in validation cohort which will be a prospective study. The clinical presentation will be recorded. The CT scans will be reviewed by two radiologists blinded to clinical details and the clinical presentation will be compared with categorisation based on the radiological findings.

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Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Conception and Validation of a Clinico-radiological Classification of Peritoneal Tuberculosis
Actual Study Start Date : May 1, 2019
Actual Primary Completion Date : April 30, 2020
Actual Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Group/Cohort Intervention/treatment
Peritoneal Tuberculosis
Patients diagnosed with peritoneal tuberculosis and who have undergone a computed tomographic examination
Other: Radiological assessment
Radiological assessment of findings in the peritoneum, omentum, mesentery, ascites and other abdominal findings




Primary Outcome Measures :
  1. Correlation of radiological characterization of classification with clinical presentation [ Time Frame: 3 months of diagnosis ]
    Clinical presentation will be classified as 1) Distension dominant 2) Pain dominant 3) Obstruction dominant This will be correlated with the categorisation based on radiologic findings and correlation between the radiological category an actual clinical category will be studied



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with peritoneal tuberculosis or being treated as peritoneal tuberculosis
Criteria

Inclusion Criteria

  • Patients diagnosed with peritoneal tuberculosis
  • Patients who have undergone a computed tomographic examination

Exclusion Criteria:

  • Age < 12
  • Unclear diagnosis
  • More than one etiology for ascites
  • Not willing for consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927664


Locations
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India
Postgraduate Institute of Medical Education and Research
Chandigarh, India, 160036
Department of Gastroenterology, Postgraduate Institute of Medical Education and Research, Chandigarh
Chandigarh, India
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
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Principal Investigator: Vishal Sharma Postgraduate Institute of Medical Education and Research
Publications:
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Responsible Party: Vishal Sharma, Assistant Professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT03927664    
Other Study ID Numbers: NK/5243/Study/019
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tuberculosis
Peritonitis, Tuberculous
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Peritonitis
Intraabdominal Infections
Infection
Peritoneal Diseases
Digestive System Diseases