A New Anatomical Classification of Portal Vein Location of Pancreas Tumors
Primary Purpose
Pancreatic Neoplasm Malignant Head Primary
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
primary repair
segmental resection
graft reconstruction
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Neoplasm Malignant Head Primary focused on measuring pancreas tumors
Eligibility Criteria
Inclusion Criteria:
- This retrospective cohort study identified all consecutive patients with T3 (stage IIA to III) adenocarcinoma of the head of the pancreas, who underwent concomitant venous (PV/SMV) resection.
Exclusion Criteria:
- Those patients with locally advanced tumors that were not responded to neoadjuvant therapy were excluded.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Level 1
Level II
Level III
Arm Description
Those tumors located superior to the portal confluence were classified as Level I,
those tumors located on the confluence (involving the confluence) located on the portal confluence
those tumors located inferior to the portal confluence
Outcomes
Primary Outcome Measures
peri-operative or postoperative complication
surgical complications observed during both operative and postoperative period
Secondary Outcome Measures
hospital stay
the time between the day of surgery and hospital discharge
Full Information
NCT ID
NCT04416685
First Posted
May 31, 2020
Last Updated
May 5, 2022
Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04416685
Brief Title
A New Anatomical Classification of Portal Vein Location of Pancreas Tumors
Official Title
A New Anatomical Classification of Portal Venous Involvement in Locally Advanced Pancreatic Cancer to Predict the Surgical Difficulty
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2014 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
May 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this retrospective study, we recorded the location of pancreatic tumors and relation/proximity to the portal vein. The surgical difficulty and requirement of additional interventions were also evaluated.
Detailed Description
Between May 2014 and October 2018, all patients who underwent PD procedure were retrospectively reviewed. This retrospective cohort study identified all consecutive patients with T3 (stage IIA to III) adenocarcinoma of the head of the pancreas, who underwent concomitant venous (PV/SMV) resection. Those patients with locally advanced tumors that were not responded to neoadjuvant therapy were excluded. The local ethical committee was approved this study.
Data collection included demographical features, tumor characteristics including the PV level of the tumor considering computed tomography results, neoadjuvant therapy, surgical data, hospital stay, morbidity and mortality.
Anatomical classification was established based on the relationship between portal confluence (PC) and tumor location (Figure I). Those tumors located superior to the PC were classified as Level I, whereas tumors on the confluence inferiorly located to PC were classified as Level II and Level III.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasm Malignant Head Primary
Keywords
pancreas tumors
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Anatomical classification was established based on the relationship between portal confluence (PC) and tumor location . Those tumors located superior to the PC were classified as Level I, whereas tumors on the confluence inferiorly located to PC were classified as Level II and Level III.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Level 1
Arm Type
Other
Arm Description
Those tumors located superior to the portal confluence were classified as Level I,
Arm Title
Level II
Arm Type
Other
Arm Description
those tumors located on the confluence (involving the confluence) located on the portal confluence
Arm Title
Level III
Arm Type
Other
Arm Description
those tumors located inferior to the portal confluence
Intervention Type
Procedure
Intervention Name(s)
primary repair
Intervention Description
For Level I-II tumors, in case of segmental resection of PV/SMV, the reconstruction was performed by an end-to-end anastomosis either by direct suture (for defect under 2 cm) or by using an interposition venous or prosthetic graft. For this purpose, autologous grafting we used internal jugular vein and cadaveric iliac vein and alternatively, synthetic PTFE graft was also used.
Intervention Type
Procedure
Intervention Name(s)
segmental resection
Other Intervention Name(s)
primary repair
Intervention Description
For Level I-II tumors, in case of segmental resection of PV/SMV, the reconstruction was performed by an end-to-end anastomosis either by direct suture (for defect under 2 cm) or by using an interposition venous or prosthetic graft. For this purpose, autologous grafting we used internal jugular vein and cadaveric iliac vein and alternatively, synthetic PTFE graft was also used.
Intervention Type
Procedure
Intervention Name(s)
graft reconstruction
Other Intervention Name(s)
segmental resection
Intervention Description
Regarding Level III tumors, complete resection of the tumor was done either by tangential excision or by partial venous excision and subsequent reconstruction. To maintain a secure anastomosis, the mesenteric root was mobilized completely or/and splenic vein was divided.
Primary Outcome Measure Information:
Title
peri-operative or postoperative complication
Description
surgical complications observed during both operative and postoperative period
Time Frame
up to one month
Secondary Outcome Measure Information:
Title
hospital stay
Description
the time between the day of surgery and hospital discharge
Time Frame
up to one month
Other Pre-specified Outcome Measures:
Title
in hospital mortality
Description
any mortality after/during surgery in the initial hospital stay
Time Frame
up to two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
This retrospective cohort study identified all consecutive patients with T3 (stage IIA to III) adenocarcinoma of the head of the pancreas, who underwent concomitant venous (PV/SMV) resection.
Exclusion Criteria:
Those patients with locally advanced tumors that were not responded to neoadjuvant therapy were excluded.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
any question about details can be shared via e-mail privately.
Learn more about this trial
A New Anatomical Classification of Portal Vein Location of Pancreas Tumors
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