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Does Timing of Completion Radical Cholecystectomy Determine the Survival in Incidental Carcinoma Gallbladder (IGBC)

Does Timing of Completion Radical Cholecystectomy Determine the Survival Outcome in Incidental Carcinoma Gallbladder - a Single Center Retrospective Analysis

Various factors determine the long term survival in this non-uniform cohort of incidental gallbladder cancer. Timing of re-intervention is suggested to play an important role in the outcome. Few centers are proponents of early surgery in order to prevent dissemination, while others have suggested an intentional delay of 3 months to filter out cases with aggressive pathology. In the present study, investigators intend to evaluate the factors affecting survival in incidental Gallbladder Cancer (IGBC) with special reference to timing of re-intervention.

研究概览

地位

完全的

条件

详细说明

Surgical Gastroenterology department at our institute is a tertiary referral center for hepatobiliary malignancies; covering a large part of North and North-east India. The details and progress reports of patients of Gallbladder Cancer (GBC) being referred to and treated at the institute is maintained in a prospective manner on hospital data base. This includes demographic data, presenting complains, details of relevant investigations done outside and in the hospital, previous surgery, pre-hospital course, operative findings, post operative course and final histopathology. Being a retrospective analysis of data not affecting clinical outcomes, ethical approval was not taken. During the study period (Jan 2009 to Dec 2018), 1049 participants with diagnosis of GBC (including 91 IGBC participants) were admitted; 239/958 participants with diagnosis of GBC and 48/91 with diagnosis of GBC could undergo resection with curative intent. Information regarding adjuvant therapy, recurrence, and survival were retrieved through data maintained on follow up out-patient cards till December 2019. Few participants who stopped visiting the hospital were contacted telephonically or through letters. All available histopathology blocks and slides following the index cholecystectomy were re-reviewed by the pathologists in the institute. Tumor type, differentiation and primary T stage were documented for majority of cases. Interval between index cholecystectomy and date of re-operation was calculated for all the participants and divided into 3 groups: Early (<4weeks), Intermediate (4-12 weeks) and Late (>12 weeks). Primary objective was to assess the effect of tumor characteristics and the time gap (between index surgery and re-resection) on overall survival following curative (R0/R1) resection.

研究类型

观察性的

注册 (实际的)

48

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

All incidental carcinoma gallbladder patients who were admitted for possible curative resection during the study period (Jan 2009 to Dec 2018)

描述

Inclusion Criteria:

All incidental carcinoma gallbladder patients who could undergo curative resection during the study period (Jan 2009 to Dec 2018)

Exclusion Criteria:

Metastasis on preoperative investigation or on staging laparoscopy

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Early (<4weeks), Intermediate (4-12 weeks) and Late (>12 weeks)
Interval between index cholecystectomy and radical re-resection with curative intent

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Survival based on timing of completion radical cholecystectomy
大体时间:01.01.2009 to 31.12.2018
Overall and disease free survival
01.01.2009 to 31.12.2018

次要结果测量

结果测量
措施说明
大体时间
Determinants of factors associated with survival in incidental gallbladder carcinoma
大体时间:01.01.2009 to 31.12.2018
Factors related to primary surgery (residual disease, primary T stage), type of resection (Wedge resection, Segment 4B-5 excision or Common bile duct excision), tumor characteristics (differentiation and lymohovascular invasion) and final stage (AJCC 8th edition)
01.01.2009 to 31.12.2018

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2009年1月1日

初级完成 (实际的)

2018年12月31日

研究完成 (实际的)

2021年10月1日

研究注册日期

首次提交

2021年10月11日

首先提交符合 QC 标准的

2021年11月5日

首次发布 (实际的)

2021年11月10日

研究记录更新

最后更新发布 (实际的)

2021年11月10日

上次提交的符合 QC 标准的更新

2021年11月5日

最后验证

2021年11月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

IPD 计划说明

The final data sheet can be shared and not the individual data as the data was retrieved from online database

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Curative surgery的临床试验

3
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