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

Sponsor
Institute of Liver and Biliary Sciences, India (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05389917
Collaborator
(none)
25
12.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Pancreaticoduodenectomy

Detailed Description

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

Study Design

Study Type:
Observational
Anticipated Enrollment :
25 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Three-Dimensional Vascular Reconstruction of the Pancreas on Multidetector Computed Tomography Images and Its Impact on Patients Undergoing Pancreaticoduodenectomy - A Prospective Observational Study
Anticipated Study Start Date :
May 30, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Consecutive adult patients undergoing pancreaticoduodenectomy

All the consecutive patients who undergo pancreaticoduodenectomy will be recruited into the study after obtaining informed consent

Procedure: Pancreaticoduodenectomy
In Pre Operative phase 64 Slice MD CT scan will be taken in all patients undergoing PD in pre op period 3D reconstruction of Peripancreatic vascular system using MDCT images Measure longitudinal distance between Root of Left renal vein, origin of IPDA Measure distance between origin of SMA , MCA and the IPDA In Intraoperative period Distance will be measured using standard disposable ruler from Root of Left renal vein to IPDA after Transection of Pancreas followed by specimen removal and to measure the distance between MCA, SMA and IPDA using standard disposable ruler .

Outcome Measures

Primary Outcome Measures

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

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

Secondary Outcome Measures

  1. 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]

    During the procedure distance will be measured between Origin of SMA and MCA to Origin of IPDA

  2. To correlate the early ligation of IPDA with Blood Loss and Operative time [During the Procedure]

    Blood Loss during the procedure and time required to complete the pancreaticoduodenectomy procedure

  3. Spectrum of arterial anomalies encountered during Pancreaticoduodenectomy [During The Procedure]

    Anatomy of vascular arcades arising from the celiac and superior mesenteric arteries will be noted during the procedure

  4. 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]

    Operative time of patients who have undergone pancreaticoduodenectomy during the study period is compared with historical cohorts

  5. 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]

    Blood loss of patients who have undergone pancreaticoduodenectomy during the study period is compared with historical cohorts

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

• Consecutive Patients undergoing pancreaticoduodenectomy during the study period at ILBS

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Institute of Liver and Biliary Sciences, India

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier:
NCT05389917
Other Study ID Numbers:
  • IEC/2022/92/MA10
First Posted:
May 25, 2022
Last Update Posted:
May 25, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Institute of Liver and Biliary Sciences, India

Study Results

No Results Posted as of May 25, 2022