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An observational single-centre study to find out does regular monitoring of a specialised blood test ( serum Ca 19.9 measurement) helps in the early detection of recurrence of gallbladder cancer after surgery.

The Role of Serial Serum Carbohydrate Antigen 19-9 Surveillance to Detect Recurrences after Radical Curative Resection for Gallbladder Carcinoma - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/07/090747
Enrollment
813
Registered
2025-07-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C23- Malignant neoplasm of gallbladder

Interventions

Intervention1: Nil: Nil Control Intervention1: NIL: NIL

Sponsors

Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Consecutive adult patients more than 18 years of both sexes with Gallbladder carcinoma who underwent curative radical resection 2. Date of surgery between 01 Jan 2010 to 31Jan2024

Exclusion criteria

Exclusion criteria: 1. Date of surgery outside the study period 2. Patients with non-malignant pathology, non-adenocarcinoma histology, metastatic disease, non-radical surgery, and R plus resections. 3.CA 19-9 non-secretors (undetectable serum CA 19-9 levels less than 2 U per ml) Patients who have no post-operative CA 19-9 values available

Design outcomes

Primary

MeasureTime frame
The sensitivity, and specificity for the first raised postoperative CA 19-9 level, the serial rise in serum CA 19-9, and the relative rise and absolute cut-off value of serum CA 19-9 for the diagnosis of recurrenceTimepoint: 6 months—

Secondary

MeasureTime frame
The positive predictive value, and negative predictive value for the first raised postoperative CA 19-9 level, the serial rise in serum CA 19-9, and the relative rise and absolute cut-off value of serum CA 19-9 for the diagnosis of recurrence.Timepoint: 6 months—

Countries

India

Contacts

Public ContactDr Shraddha Patkar

Tata Memorial Hospital, Mumbai

drshraddhapatkar@gmail.com9820074818

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026