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临床试验/NCT05389917
NCT05389917Unknown不适用

Three-Dimensional Vascular Reconstruction of the Pancreas on Multidetector Computed Tomography Images and Its Impact on Patients Undergoing Pancreaticoduodenectomy - A Prospective Observational Study

Institute of Liver and Biliary Sciences, India0 个研究点目标入组 25 人开始时间: 2022年5月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
25
主要终点
Probability of identifying IPDA with in 1 cm of anticipated location from Left renal vein determined by preoperative 3D reconstructed MDCT images.

研究概览

简要总结

Three-Dimensional Vascular Reconstruction of the Pancreas on Multi detector Computed Tomography images and its impact on patients undergoing Pancreatoduodenectomy - A Prospective Observational Study IPDA is difficult to identify in pre op in routine CECT images IPDA is difficult to identify in intra op Identification of those major blood vessels (SMA, MCA, Left Renal vein) that lie around the IPDA and then to measure the distances between these major vessels and the IPDA, helps to determine the location of the IPDA

详细描述

Pancreaticoduodenectomy (PD) is a complex surgical procedure performed for benign and malignant indications .

Vascular anatomy of the pancreatic head, is important in multiple aspects

  • Classical arterial anatomy is observed in 55-79% of cases
  • Arterial Variation is observed in around 25-30% of cases
  • Relationship of the tumor to the blood vessels determines the resectability of tumor The presence of anatomical variations may increase the risk of complications through
  • direct (bleeding due to intraoperative vessel injury)
  • indirect (postoperative ischemia of tissues and anastomotic leakage) Preoperative understanding of the vascular anatomy of the pancreatic head is important in order to reduce intraoperative bleeding.
  • IPDA is difficult to identify in pre op in routine CECT images. It is identified in only 20% of patients.
  • IPDA is difficult to identify in intra op because- It generally originates from the posterior wall of superior mesenteric artery (SMA).The origin of IPDA frequently varies, which makes it difficult to identify in some patients. It is surrounded by dense lymphovascular tissue, which makes it difficult to identify IPDA during surgery.

IPDA can be identified in up to 86% of the time using 3D MDCT . Identification of those major blood vessels (SMA, MCA, Left Renal vein) that lie around the IPDA and then to measure the distances between these major vessels and the IPDA, helps to determine the location of the IPDA.

In the existing studies, they have not defined the impact of identifying IPDA on intra operative parameters ( Operative time, Blood loss) These studies have not used uniform landmarks in the identification of IPDA

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Consecutive Patients undergoing pancreaticoduodenectomy during the study period at ILBS

排除标准

  • If surgery is not proceeded for any cause like Presence of metastasis, Unreconstructable portal or SMV involvement , SMA involvement of >180 degree
  • Refusal for consent

结局指标

主要结局

Probability of identifying IPDA with in 1 cm of anticipated location from Left renal vein determined by preoperative 3D reconstructed MDCT images.

时间窗: During the Procedure

During the procedure distance will be measured between root of Left Renal vein to Origin of IPDA

次要结局

  • To compare operative time between patients who undergo pre operative 3D vascular reconstruction on MD CT followed by Pancreaticoduodenectomy versus historical controls who have undergone pancreaticoduodenectomy at ILBS(During the Procedure)
  • To compare blood loss between patients who undergo pre operative 3D vascular reconstruction on MD CT followed by Pancreaticoduodenectomy versus historical controls who have undergone pancreaticoduodenectomy at ILBS(During the Procedure)
  • To correlate the location of IPDA predicted by 3D reconstruction of preoperative MDCT images with actual intraoperative location of MCA and SMA, after specimen removal(During the Procedure)
  • To correlate the early ligation of IPDA with Blood Loss and Operative time(During the Procedure)
  • Spectrum of arterial anomalies encountered during Pancreaticoduodenectomy(During The Procedure)

研究者

申办方类型
Other
责任方
Sponsor

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