Clinico-radiological Classification of Peritoneal Tuberculosis

Conception and Validation of a Clinico-radiological Classification of Peritoneal Tuberculosis

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.

Study Overview

• Status: Completed
• Conditions: Tuberculosis; Tuberculosis; Abdomen (Etiology); Tuberculosis, Peritoneal
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160036
    • Postgraduate Institute of Medical Education and Research
  • Chandigarh, India
    • Department of Gastroenterology, Postgraduate Institute of Medical Education and Research, Chandigarh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with peritoneal tuberculosis or being treated as peritoneal tuberculosis

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of radiological characterization of classification with clinical presentation	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	3 months of diagnosis

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research
• Investigators: Principal Investigator: Vishal Sharma, Postgraduate Institute of Medical Education and Research

Publications and helpful links

General Publications

• Ahamed Z R, Shah J, Agarwala R, Kumar-M P, Mandavdhare HS, Gupta P, Singh H, Sharma A, Dutta U, Sharma V. Controversies in classification of peritoneal tuberculosis and a proposal for clinico-radiological classification. Expert Rev Anti Infect Ther. 2019 Aug;17(8):547-555. doi: 10.1080/14787210.2019.1642746. Epub 2019 Jul 17.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): July 30, 2020

Study Registration Dates

• First Submitted: April 22, 2019
• First Submitted That Met QC Criteria: April 23, 2019
• First Posted (Actual): April 25, 2019

Study Record Updates

• Last Update Posted (Actual): August 31, 2020
• Last Update Submitted That Met QC Criteria: August 28, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Peritoneal Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Intraabdominal Infections; Peritonitis; Tuberculosis; Peritonitis, Tuberculous
• Other Study ID Numbers: NK/5243/Study/019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No