TOR 1
2015-16
The research proposal for a hospital-based cohort study titled “Cost-effective non-invasive diagnostic modalities and predictive model for the development and progression of fibrosis among patients with Hepatitis B, Hepatitis C infection, or non-alcoholic fatty liver disease” was approved by the Institute’s Ethical Committee (IEC) on January 9, 2016.
• The study was registered on ClinicalTrials.gov with the identifier number NCT02658786, and the research commenced.
• The retrospective cohort consisted of 3006 cases that underwent biopsy from 2010 to 2015. This group included 1685 cases of HBV, 532 cases of HCV, and 789 cases of NAFLD.
2016-17
The prospective phase began in January 2016, enrolling 622 cases to date:
• 325 Non-Alcoholic Fatty Liver Disease patients
• 238 Hepatitis B cases
• 59 Hepatitis C cases
• Effective treatment availability reduced the need for biopsies, making it challenging to enroll 1000 HCV cases.
2017-18
• 640 cases had been enrolled in the study up to the current date.
• Among these cases, 333 were patients with Non-Alcoholic Fatty Liver Disease, 245 were Hepatitis B (HBV) cases, and 62 were Hepatitis C (HCV) cases.
• Over the past 4 years, a total of 1050 biopsies were conducted for Hepatitis B cases.
• Within the same 4-year period, a total of 375 biopsies were performed for Hepatitis C cases.
2019-20
Activities Undertaken:
• Surveillance of etiological factors for Cirrhosis and HCC was conducted.
• Hospital-based registries were initiated for Cirrhosis and Hepatocellular carcinoma patients in 13 centers of excellence in Hepatology across the country.
• Out of these 13 centers, 6 centers obtained ethical clearance and commenced data collection, while others were in the process of seeking ethical approval.
Outputs Provided:
Surveillance of etiological factors for Cirrhosis and HCC was carried out.
• Hospital-based registries were initiated for Cirrhosis and Hepatocellular carcinoma patients in 13 centers of excellence in Hepatology across the country.
• Among these centers, 6 centers received ethical clearance and initiated data collection, with the rest in the process of seeking ethical approval.
• The overall enrollment status of subjects included:
o A total of 2210 participants were registered in the surveillance.
o Approximately 83% of the participants were male.
o Nearly 98% of the participants were diagnosed with liver cirrhosis, with around 51% having non-compensated liver cirrhosis.
o About 28% of the participants were diagnosed with hepatocellular cancer.
o Around 13% of participants tested positive for HBsAg.
o Approximately 6% of participants had a positive HCV RNA test result.
2020-21
Key findings of sequelae surveillance:
Number of cases
• Cirrhosis 1032 (81.65)
• Hepatocellular carcinoma 818 (64.72)
• Total 1264 (100)
Number of cases from each participating center
• Institute of Liver and Biliary Sciences 182 (17.64) 306 (37.41)
• All India Institute of Medical Sciences, Delhi 65 (6.30) 17 (2.08))
• Post Graduate Institute of Medical and Educational Research, Chandigarh 110 (10.56) 23 (2.81)
• DMCH, Ludhiana 47 (4.55) 49 (5.99)
• Christian Medical College, Vellore 295 (28.59) 320 (39.12)
• Asian Institute of Gastroenterology, Hyderabad 39 (3.78) 37 (4.52)
• Chothiram Hospital and Research Centre, Indore 294 (28.49) 66 (8.07)
2021-22
Key findings of sequelae surveillance:
Number of cases
• Cirrhosis 1815 (78.16)
• Hepatocellular carcinoma 1322 (56.93)
• Total 2322
Number of cases from each participating centre
• Institute of Liver and Biliary Sciences 703 (38.73) 611 (46.21)
• Post Graduate Institute of Medical and Educational Research, Chandigarh 111 (6.11) 41 (3.10)
• DMCH, Ludhiana 579 (31.9) 552 (41.75)
• Christian Medical College, Vellore 65 (3.58) 69 (5.21)
• Institute of Liver Diseases, Global Hospital, Mumbai 6 (0.33) 5 (0.37)
• Choithram Hospital and Research Centre, Indore 350 (19.28) 43 (3.25)