PancreaticoduodenectomyNCT05389917
Three-Dimensional Vascular Reconstruction of the Pancreas on Multidetector Computed Tomography Images and Its Impact on Patients Undergoing Pancreaticoduodenectomy
An observational study of Pancreaticoduodenectomy, run by Institute of Liver and Biliary Sciences, India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreaticoduodenectomy
- What is being tested?
- Pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2022to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive adult patients undergoing pancreaticoduodenectomy during the study period at ILBS
Who may be able to join
- Consecutive Patients undergoing pancreaticoduodenectomy during the study period at ILBS
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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
- Conditions
- Pancreaticoduodenectomy
- Being tested
- Pancreaticoduodenectomy
- Keywords
- Inferior Pancreaticoduodenal artery, Multi detector Computed Tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PancreaticoduodenectomyProcedure or surgery
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 .
| Study group | Role | What they receive |
|---|---|---|
| Consecutive adult patients undergoing pancreaticoduodenectomy | All the consecutive patients who undergo pancreaticoduodenectomy will be recruited into the study after obtaining informed consent Receives: Procedure: Pancreaticoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 distance will be measured between Origin of SMA and MCA to Origin of IPDA
Measured: During the Procedure
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
Measured: During the Procedure
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
Measured: 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
Operative time of patients who have undergone pancreaticoduodenectomy during the study period is compared with historical cohorts
Measured: 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
Blood loss of patients who have undergone pancreaticoduodenectomy during the study period is compared with historical cohorts
Measured: During the Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start30 May 2022 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PancreaticoduodenectomyStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389917
- Sponsor's protocol ID
- IEC/2022/92/MA10
- Status last verified
- May 2022
- First submitted
- 9 May 2022
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 28099958Horiguchi 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 20714842Fang 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 24622068Perwaiz 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 20065548Sim 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 8875875Patel 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
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05389917
- Acronym / sponsor ID
- IEC/2022/92/MA10
- Conditions
- Pancreaticoduodenectomy
- Keywords
- Inferior Pancreaticoduodenal artery, Multi detector Computed Tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 30 May 2022 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Consecutive adult patients undergoing pancreaticoduodenectomy | – | Procedure: PancreaticoduodenectomyAll the consecutive patients who undergo pancreaticoduodenectomy will be recruited into the study after obtaining informed consent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult patients undergoing pancreaticoduodenectomy during the study period at ILBS
Key inclusion criteria (1 listed)
- Consecutive Patients undergoing pancreaticoduodenectomy during the study period at ILBS
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PancreaticoduodenectomyIn 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 . | Procedure or surgery | Consecutive adult patients undergoing pancreaticoduodenectomy |
Primary outcome
Probability of identifying IPDA with in 1 cm of anticipated location from Left renal vein determined by preoperative 3D reconstructed MDCT images.
Time frame: During the Procedure
During the procedure distance will be measured between root of Left Renal vein to Origin of IPDA
5 secondary outcomes
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
Time frame: During the Procedure
To correlate the early ligation of IPDA with Blood Loss and Operative time
Time frame: During the Procedure
Spectrum of arterial anomalies encountered during Pancreaticoduodenectomy
Time frame: 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
Time frame: 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
Time frame: During the Procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Background: PubMed 28099958Tomimaru 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.
- Background: PubMed 20714842Horiguchi 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.
- Background: PubMed 24622068Fang 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.
- Background: PubMed 20065548Perwaiz 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.
- Background: PubMed 8875875Sim 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.
- Background: PubMed 24434918Patel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreaticoduodenectomy, run by Institute of Liver and Biliary Sciences, India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manoj Kumar YL, MBBS, MS (9164313430, manojkumaryl91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probability of identifying IPDA with in 1 cm of anticipated location from Left renal vein determined by preoperative 3D reconstructed MDCT images. (time frame: During the Procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05389917, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.