临床试验/CTRI/2024/12/077630

CTRI/2024/12/077630招募中4 期

To Determine Efficacy and Safety of Open vs Laparoscopic Radical Cholecystectomy (LRC) among patients with Early Gallbladder Cancer (GBC) - a Randomized Controlled Trial

Dr Shikha Tiwari1 个研究点分布在 1 个国家目标入组 42 人开始时间: 2024年12月16日最近更新: 2024年12月4日

试验速览

阶段: 4 期
状态: 招募中
发起方
入组人数: 42
试验地点: 1
主要终点: Operative time and ease of performance

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a randomized, open label, parallel group, active controlled trial determining the efficacy of and safety of open vs laparoscopic radical cholecystectomy (LRC) among patients with early gallbladder cancer. The study will be conducted in multiple health institutes in India. Primary outcome measure will be operative time and ease of performance and Incidence of early recurrence that is within 6 months, secondary outcomes will be duration of hospital stay in days, and cost effectiveness.

研究设计

研究类型: Interventional
分配方式: Coin toss, Lottery, toss of dice, shuffling cards etc
盲法: None

入排标准

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

入选标准

•Patients in age group 18 years or above with stage I and II (incidental early gallbladder cancer found on biopsy after simple cholecystectomy).
•Patients with suspected gallbladder cancer without evidence of liver invasion or extrahepatic bile duct involvement at enhanced abdominal CT scan.

排除标准

•Involvement of aortocaval lymph nodes and lymph nodes along celiac trunk on preoperative Computed Tomography scan Patients with distant metastasis.

结局指标

主要结局

Operative time and ease of performance

时间窗: at baseline

Incidence of early recurrence ( within 6 months)

时间窗: at baseline

次要结局

Cost effectiveness
Average duration of hospital stay(till the patient is discharged)

研究者

发起方

Dr Shikha Tiwari

申办方类型

Other [Self (Principal Investigator)]

责任方

Principal Investigator

主要研究者

Dr Shikha Tiwari

GSVM Medical College, Kanpur

研究点 (1)

Loading locations...

相似试验

招募中

不适用

Laparoscopic Versus Open Surgery for Colon Cancer With Visceral Obesity

NCT07314996Second Affiliated Hospital, School of Medicine, Zhejiang University664

已完成

不适用

vNOTES vs Laparoscopic Hysterectomy: Randomized Trial on Pain and Recovery"

NCT07306507Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital90

招募中

不适用

Outcomes After Laparoscopic Versus Open PancreaticoduodenectomyPancreatic Neuroendocrine Tumor

NCT07328607Minia University90

招募中

3 期

Neoadjuvant/Adjuvant AK104 in Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer

NCT07412613Akeso386

尚未招募

3 期

Comparison of laparoscopic totally extraperitoneal hernia repair with and without prophylactic antibiotics.

CTRI/2024/12/078131Maulana Azad Medical College and Associated Lok Nayak Hospital20