跳至主要内容
临床试验/NCT07480005
NCT07480005招募中不适用

To Revisit the Yield of Staging Laparoscopy in Hepatopancreatobiliary Malignancies

Institute of Liver and Biliary Sciences, India1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2026年3月18日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
350
试验地点
1
主要终点
the yield of staging laparoscopy in HPB malignancies

研究概览

简要总结

This research project, to be conducted at the Institute of Liver & Biliary Sciences, aims to evaluate the effectiveness of staging laparoscopy (SL) in detecting occult metastases in hepatopancreatobiliary (HPB) malignancies in the current era of advanced imaging modalities such as MDCT, MRI, EUS, and PET-CT. While SL is a minimally invasive technique that aids in identifying radiologically undetectable metastases, its utility in routine practice is under scrutiny due to improved imaging accuracy. The study is premised on the hypothesis that the yield of SL is low in the current imaging era, questioning its routine application.

The study uses an ambispective cohort design and includes all patients undergoing SL for HPB malignancies from January 2012 to March 2026 at ILBS, Delhi. The primary objective is to assess the yield of SL, while secondary objectives include evaluating false positives/negatives, the added value of PET-CT over CT, and identifying clinical or radiological predictors of positive SL.

Subgroup analyses will be performed for different HPB cancers including periampullary malignancies, gallbladder cancer, hilarcholangiocarcinoma, intrahepatic cholangiocarcinoma, pancreatic ductal adenocarcinoma, and hepatocellular carcinoma. Data collection includes demographics, tumor markers, imaging findings, SL results, duration, and associated costs.

Findings from this study could inform refined criteria for the selective use of SL, avoiding unnecessary surgeries and optimizing resource utilization. This could lead to evidence-based guidelines for staging practices in HPB cancers, balancing clinical benefits against costs and surgical risks in the context of modern diagnostic capabilities.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients with suspected HPB malignancies undergoing staging laparoscopy before proceeding to laparotomy.
  • Pre-op CT scans of cut size less than or equal to 1.5 mm

排除标准

  • Patients undergoing staging laparoscopy without intent of curative resection in the same sitting.
  • malignancies other than adenocarcinoma
  • Final histopathology is benign

研究组 & 干预措施

carcinoma gall bladder

suspected CaGb patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of adenocarcinoma of gall bladder

干预措施: No intervention (Other)

Hepatocellular carcinoma

suspected HCC patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of HCC

干预措施: No intervention (Other)

Perihilar and hilar cholangiocarcinoma

suspected Perihilar and hilar cholangiocarcinoma patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of adenocarcinoma

干预措施: No intervention (Other)

Peri-ampullary Malignancy

suspected Peri-ampullary Malignancy patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of adenocarcinoma

干预措施: No intervention (Other)

Intrahepatic cholangiocarcinoma

suspected Intrahepatic cholangiocarcinoma patients based on preoperative imaging undergoing staging laparoscopy and the final histopathology suggestive of adenocarcinoma

干预措施: No intervention (Other)

结局指标

主要结局

the yield of staging laparoscopy in HPB malignancies

时间窗: DAY 0

proportion of patients with positive staging laparoscopy (Metastatic disease/unresectable) findings leading to abandonement of procedure

次要结局

  • Positive findings on SL leading to abandonment(DAY 0)
  • False positive findings(DAY 0)
  • Additional findings reported on laparotomy after SL(DAY 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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