NCT05389917

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

May 30, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

May 25, 2022

Status Verified

May 1, 2022

Enrollment Period

1 year

First QC Date

May 9, 2022

Last Update Submit

May 21, 2022

Conditions

Keywords

Inferior Pancreaticoduodenal arteryMulti detector Computed Tomography

Outcome Measures

Primary Outcomes (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 distance will be measured between root of Left Renal vein to Origin of IPDA

    During the Procedure

Secondary Outcomes (5)

  • 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

  • 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

Study Arms (1)

Consecutive adult patients undergoing pancreaticoduodenectomy

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

Procedure: Pancreaticoduodenectomy

Interventions

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 .

Consecutive adult patients undergoing pancreaticoduodenectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive adult patients undergoing pancreaticoduodenectomy during the study period at ILBS

You may qualify if:

  • Consecutive Patients undergoing pancreaticoduodenectomy during the study period at ILBS

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Tomimaru Y, Tanaka K, Noguchi K, Hatano H, Eguchi H, Dono K. Distance from Left Renal Vein to Inferior Pancreaticoduodenal Artery: A Landmark for Identifying Inferior Pancreaticoduodenal Artery in Pancreatoduodenectomy. Dig Surg. 2017;34(4):335-339. doi: 10.1159/000453553. Epub 2017 Jan 19.

    PMID: 28099958BACKGROUND
  • Horiguchi A, Ishihara S, Ito M, Asano Y, Yamamoto T, Miyakawa S. Three-dimensional models of arteries constructed using multidetector-row CT images to perform pancreatoduodenectomy safely following dissection of the inferior pancreaticoduodenal artery. J Hepatobiliary Pancreat Sci. 2010 Jul;17(4):523-6. doi: 10.1007/s00534-009-0261-9. Epub 2010 Feb 9.

    PMID: 20714842BACKGROUND
  • Fang CH, Kong D, Wang X, Wang H, Xiang N, Fan Y, Yang J, Zhong SZ. Three-dimensional reconstruction of the peripancreatic vascular system based on computed tomographic angiography images and its clinical application in the surgical management of pancreatic tumors. Pancreas. 2014 Apr;43(3):389-95. doi: 10.1097/MPA.0000000000000035.

    PMID: 24622068BACKGROUND
  • Perwaiz A, Singh A, Singh T, Chaudhary A. Incidence and management of arterial anomalies in patients undergoing pancreaticoduodenectomy. JOP. 2010 Jan 8;11(1):25-30.

    PMID: 20065548BACKGROUND
  • Sim JS, Choi BI, Han JK, Chung MJ, Chung JW, Park JH, Han MC. Helical CT anatomy of pancreatic arteries. Abdom Imaging. 1996 Nov-Dec;21(6):517-21. doi: 10.1007/s002619900117.

    PMID: 8875875BACKGROUND
  • Patel BN, Giacomini C, Jeffrey RB, Willmann JK, Olcott E. Three-dimensional volume-rendered multidetector CT imaging of the posterior inferior pancreaticoduodenal artery: its anatomy and role in diagnosing extrapancreatic perineural invasion. Cancer Imaging. 2013 Dec 30;13(4):580-90. doi: 10.1102/1470-7330.2013.0051.

    PMID: 24434918BACKGROUND

MeSH Terms

Interventions

Pancreaticoduodenectomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Manoj Kumar YL, MBBS, MS

CONTACT

Piyush Kumar Sinha, MBBS,MS,MCh

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2022

First Posted

May 25, 2022

Study Start

May 30, 2022

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

May 25, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share