TuberculosisNCT03927664
Clinico-radiological Classification of Peritoneal Tuberculosis
An observational study of Tuberculosis and Tuberculosis; Abdomen (Etiology), run by Post Graduate Institute of Medical Education and Research, Chandigarh at 2 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Tuberculosis, Tuberculosis; Abdomen (Etiology), Tuberculosis, Peritoneal
- What is being tested?
- Radiological assessment
- How many people
- 55 participants
- Where
- 2 sitesIndia
- Study dates
- 1 May 2019to 30 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with peritoneal tuberculosis or being treated as peritoneal tuberculosis
Who may be able to join
- Patients diagnosed with peritoneal tuberculosis
- Patients who have undergone a computed tomographic examination
Who cannot join
- Age < 12
- Unclear diagnosis
- More than one etiology for ascites
- Not willing for consent
Trial locations and contacts
2 sites in 1 country.
India2 sites
Postgraduate Institute of Medical Education and Research
Chandigarh, 160036
Department of Gastroenterology, Postgraduate Institute of Medical Education and Research, Chandigarh
Chandigarh
About this study
Official title: 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.
Read the detailed description
The study will be conducted as two parts
- 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.
- 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
- Distension dominant: Presence of abdominal distention or discomfort, Lack of pain
- Pain dominant: Patients having associated significant abdominal pain necessitating analgesics or interfering with routine activities
- 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.
- Being tested
- Radiological assessment
- Medical subject headings
- Tuberculosis, Peritonitis, Tuberculous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiological assessmentOther
Radiological assessment of findings in the peritoneum, omentum, mesentery, ascites and other abdominal findings
| Study group | Role | What they receive |
|---|---|---|
| Peritoneal Tuberculosis | Patients diagnosed with peritoneal tuberculosis and who have undergone a computed tomographic examination Receives: Other: Radiological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months of diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start1 May 2019
- Primary completion30 Apr 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vishal Sharma, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Vishal Sharma, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927664
- Sponsor's protocol ID
- NK/5243/Study/019
- Status last verified
- Aug 2020
- First submitted
- 22 Apr 2019
- Last updated
- 31 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 31293195
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conception and Validation of a Clinico-radiological Classification of Peritoneal Tuberculosis
- ClinicalTrials.gov ID
- NCT03927664
- Acronym / sponsor ID
- NK/5243/Study/019
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 25 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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
- Distension dominant: Presence of abdominal distention or discomfort, Lack of pain
- Pain dominant: Patients having associated significant abdominal pain necessitating analgesics or interfering with routine activities
- 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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peritoneal Tuberculosis | – | Other: Radiological assessmentPatients diagnosed with peritoneal tuberculosis and who have undergone a computed tomographic examination |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with peritoneal tuberculosis or being treated as peritoneal tuberculosis
Key inclusion criteria (2 listed)
- Patients diagnosed with peritoneal tuberculosis
- Patients who have undergone a computed tomographic examination
Key exclusion criteria (4 listed)
- Age < 12
- Unclear diagnosis
- More than one etiology for ascites
- Not willing for consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiological assessmentRadiological assessment of findings in the peritoneum, omentum, mesentery, ascites and other abdominal findings | Other | Peritoneal Tuberculosis |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Background: PubMed 31293195Ahamed 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vishal Sharma principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis and Tuberculosis; Abdomen (Etiology), run by Post Graduate Institute of Medical Education and Research, Chandigarh at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of radiological characterization of classification with clinical presentation (time frame: 3 months of diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03927664, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2020.