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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
Sisli Hamidiye Etfal Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Neoplasm Malignant Head Primary focused on measuring pancreas tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 31, 2020
    Last Updated
    May 5, 2022
    Sponsor
    Sisli Hamidiye Etfal Training and Research Hospital
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    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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