Clinico-radiological Classification of Peritoneal Tuberculosis

NCT ID: NCT03927664

Last Updated: 2020-08-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 55 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2020-07-30

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.

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.

Conditions

Tuberculosis; Tuberculosis; Abdomen (Etiology); Tuberculosis, Peritoneal

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Peritoneal Tuberculosis

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

Radiological assessment

Intervention Type: OTHER

Radiological assessment of findings in the peritoneum, omentum, mesentery, ascites and other abdominal findings

Interventions

Radiological assessment

Radiological assessment of findings in the peritoneum, omentum, mesentery, ascites and other abdominal findings

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: lead

Responsible Party

Vishal Sharma

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vishal Sharma

Role: PRINCIPAL_INVESTIGATOR

Post Graduate Institute of Medical Education and Research, Chandigarh

Locations

Postgraduate Institute of Medical Education and Research

Chandigarh, , India

Department of Gastroenterology, Postgraduate Institute of Medical Education and Research, Chandigarh

Chandigarh, , India

Countries

India

References

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.

Reference Type: BACKGROUND

PMID: 31293195 (View on PubMed)

Other Identifiers

NK/5243/Study/019

Identifier Type: -

Identifier Source: org_study_id