The Role of Serial Serum Carbohydrate Antigen 19-9 Surveillance to Detect Recurrences after Radical Curative Resection for Gallbladder Carcinoma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Tata Memorial Hospital
- Enrollment
- 813
- Locations
- 1
- Primary Endpoint
- 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 recurrence
Study Overview
Brief Summary
Gallbladder carcinoma (GBC) is the most common type of biliary tract cancer associated with poor outcome, especially when detected at an advanced stage. Owing to their aggressive behavior, even after surgery meant to completely remove the tumor and additional treatments like chemotherapy or radiation, this cancer often comes back. Timely detection of cancer recurrence is important because it allows consideration of second-line treatment, which can help control the disease, relieve symptoms, and possibly extend survival compared to only providing comfort care. Regular check-ups and follow-ups are key to early detection of recurrence. One possible tool for detecting recurrence is a blood test that measures carbohydrate antigen 19-9 (CA 19-9) – a substance that can be higher in people with gall bladder or pancreatic cancer. Although this test is widely used for surveillance in pancreatic cancer, its role in GBC surveillance is not yet well established. The present study looks at whether serial monitoring of serum CA 19-9 helps early detection of recurrence in GBC who underwent curative radical resection.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Consecutive adult patients more than 18 years of both sexes with Gallbladder carcinoma who underwent curative radical resection
- •Date of surgery between 01 Jan 2010 to 31Jan2024.
Exclusion Criteria
- •Date of surgery outside the study period
- •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.
Outcomes
Primary Outcomes
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 recurrence
Time Frame: 6 months
Secondary Outcomes
- 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.(6 months)
Investigators
Dr Shraddha Patkar
Tata Memorial Hospital, Mumbai