跳至主要内容
临床试验/CTRI/2025/07/090625
CTRI/2025/07/090625尚未招募不适用

Defining the role of Staging Laparoscopy in the diagnostic algorithm of gallbladder cancers

Tata Memorial Hospital1 个研究点 分布在 1 个国家目标入组 338 人开始时间: 2025年7月28日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
338
试验地点
1
主要终点
role of staging laparoscopy in the diagnostic algorithm of gallbladder cancers

研究概览

简要总结

Patients with gallbladder cancer (GBC) diagnosed at an advanced stage have poor outcomes (5-year survival rates ranging from 4 to 12%) than those diagnosed with early-stage disease (5-year survival rates of around 60-70%). Hence, a thorough preoperative evaluation is paramount for accurate staging of the disease and prognostication. This will help in reducing non-therapeutic laparotomies and surgical morbidity while also initiating systemic therapy at the earliest.

Despite the advances in imaging, the sensitivity of contrast enhanced computed tomography (CECT) for detecting metastases in GBC patients remains low, reportedly between 70 and 80%. The use of 18 Fluorodeoxyglucose positron emission tomography CT (18FDG PET CT) as an adjunct, has been shown to identify occult metastasis in almost 46% of patients with locally advanced disease. However, the accuracy of 18FDG PET CT in the detection of small nodal, liver, and peritoneal metastases smaller than 7 mm is limited by its resolution and partial volume effect.

Staging Laparoscopy (SL) has been often employed in practice to enhance the rate of detection of radiologically occult metastases, especially in patients with “high-risk” GBC. The use of SL in the diagnostic algorithm is an extrapolation from the experience of treating other gastro-intestinal malignancies.  The current study explores the possible avenues for utility of SL in the diagnostic algorithm of GBC. By developing an accurate staging tool, this research is expected to guide better clinical decision-making for patients undergoing treatment of GBCs

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • All patients where Staging Laproscopy was used in the diagnostic or treatment pathway for GBC 2.Patients with both, per primum GBC (pGBC) and incidental GBC (iGBC) will be included.

排除标准

  • Patients with incomplete EMR records.

结局指标

主要结局

role of staging laparoscopy in the diagnostic algorithm of gallbladder cancers

时间窗: 6 months

次要结局

  • percentage of missed metastases on SL and to identify clinical predictors for metastatic disease detected during SL(6 months)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Mahesh Goel

Tata Memorial Hospital, Mumbai

研究点 (1)

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