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Status unknownNCT05389917Updated May 25, 2022

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

An observational study in Pancreaticoduodenectomy, sponsored by Institute of Liver and Biliary Sciences, India. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-25.

Sponsored by Institute of Liver and Biliary Sciences, India · Observational

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Ages
18 Years and older
Sex
All
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Study 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

Read the 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

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Conditions studied

  • Pancreaticoduodenectomy

Keywords

  • Inferior Pancreaticoduodenal artery
  • Multi detector Computed Tomography
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In context

Lead sponsor

Institute of Liver and Biliary Sciences, India is the lead sponsor of 296 studies on the registry; 84 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Consecutive adult patients undergoing pancreaticoduodenectomy during the study period at ILBS

Inclusion criteria

  • Consecutive Patients undergoing pancreaticoduodenectomy during the study period at ILBS

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedurePancreaticoduodenectomy

    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 .

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What researchers measure

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

    Time frame: During the Procedure

Secondary outcomes

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

    Time frame: During the Procedure

  2. To correlate the early ligation of IPDA with Blood Loss and Operative time

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

    Time frame: During the Procedure

  3. Spectrum of arterial anomalies encountered during Pancreaticoduodenectomy

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

    Time frame: 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

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

    Time frame: During the Procedure

  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

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

    Time frame: During the Procedure

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 28099958 ↗
  • 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. PubMed 20714842 ↗
  • 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. PubMed 24622068 ↗
  • 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. PubMed 20065548 ↗
  • 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. PubMed 8875875 ↗
  • 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. PubMed 24434918 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05389917
Lead sponsor
Institute of Liver and Biliary Sciences, India
Responsible party
Sponsor
First posted
May 25, 2022
Start date
May 30, 2022 (estimated)
Primary completion
Jun 1, 2023 (estimated)
Completion
Jun 1, 2023 (estimated)
Last update
May 25, 2022

Study contacts

Manoj Kumar YL, MBBS, MS
Contact
manojkumaryl91@gmail.com
9164313430
Piyush Kumar Sinha, MBBS,MS,MCh
Contact
piyushkumarsinha@gmail.com
9540946821

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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