An observational study in Gallbladder Neoplasm Malignant Primary, sponsored by Emilio Ramos. Withdrawn at 1 site in Spain. Per ClinicalTrials.gov, last updated 2021-09-02.
Sponsored by Emilio Ramos · Observational
An incidental gallbladder carcinoma is detected in approximately 0.2% of the cholecystectomy specimens removed for presumed benign disease. In patients that meet specific criteria, a surgical re-operation is recommended to treat possible residual tumor disease not treated with the initial cholecystectomy. The presence of residual disease in the re-intervention specimen worsens the prognosis of patient survival, according to several published series. Patients with known or high-risk of residual disease may benefit from a specific strategy that would improve patient selection before attempting re-resection. A pathology-based score has been developed but has not been yet validated in an external series of patients. The use of pathological data from the initial cholecystectomy specimen could identify patients at risk of residual disease and aid in selecting a specific therapeutic strategy prior to attempting surgical re-exploration.
247 studies on the registry are indexed under Gallbladder Neoplasms; 58 are open to participants now.
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Patients with diagnosis of incidental gallbladder cancer that request therapeutic evaluation in the participating hospital centers.
Exclusion Criteria:
Participants with incidental gallbladder cancer with presence of residual disease in the re-resection specimen or in intra-operative findings.
Procedure: Radical surgery
Participants with incidental gallbladder cancer with absence of residual disease in the re-resection specimen or in intra-operative findings.
Procedure: Radical surgery
Radical surgery is proposed to participants with pT1b, pT2 or pT3 tumors in the cholecystectomy specimen without evidence of disseminated disease with staging imaging techniques. A resection of the gallbladder bed or an anatomic resection of the hepatic segments IVb/V is performed. A lymphadenectomy of the hepatic hilum is associated in all cases. Common bile duct resection is performed in patients with involvement of the cystic margin.
Residual disease
Presence of tumoral cells in the re-resection specimen or found on staging imaging techniques. It can be local (isolated non-discontinuous involvement of the vesicular bed or the cystic stump), regional (common bile duct involvement, perineural, lymph node or neighboring organ invasion), or distant (discontinuous hepatic involvement -i.e. metastases-, peritoneal carcinomatosis or port-site metastases).
Time frame: Immediately after surgery in operated patients / within 1 year in non-operated patients
Gallbladder cancer risk score
Pathology-based score that uses T stage, grade of differentiation, presence of lymphovascular and perineural invasion evaluated in the cholecystectomy specimen to pre-operatively predict the presence of residual disease after radical resection. Each factor is assigned a value. Adding these values results in a total risk score that ranges between 3 and 10 points. The scores are separated intro three risk groups: low (3-4), intermediate (5-7) and high (8-10).
Time frame: Baseline
Disease-specific survival
Interval between date of surgical re-exploration and date of last follow-up or death. Only death from cancer will be considered an event in the analysis. Non-cancer related deaths will be excluded from the analysis.
Time frame: 1, 3, and 5-year disease-specific survival.
Disease-free survival
Interval between date of surgical re-exploration and date of recurrence diagnosis (clinic, radiologic or pathologic) or last follow-up or death in patients without recurrence.
Time frame: 1, 3, and 5-year disease-free survival.
Plan to share: No
This study is withdrawn, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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