NCT04416685

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Status
completed

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

Study Start

First participant enrolled

May 1, 2014

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
Last Updated

May 11, 2022

Status Verified

April 1, 2022

Enrollment Period

4.4 years

First QC Date

May 31, 2020

Last Update Submit

May 5, 2022

Conditions

Keywords

pancreas tumors

Outcome Measures

Primary Outcomes (1)

  • peri-operative or postoperative complication

    surgical complications observed during both operative and postoperative period

    up to one month

Secondary Outcomes (1)

  • hospital stay

    up to one month

Other Outcomes (1)

  • in hospital mortality

    up to two months

Study Arms (3)

Level 1

OTHER

Those tumors located superior to the portal confluence were classified as Level I,

Procedure: primary repairProcedure: segmental resection

Level II

OTHER

those tumors located on the confluence (involving the confluence) located on the portal confluence

Procedure: primary repairProcedure: segmental resection

Level III

OTHER

those tumors located inferior to the portal confluence

Procedure: segmental resectionProcedure: graft reconstruction

Interventions

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.

Level 1Level II

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.

Also known as: primary repair
Level 1Level IILevel III

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.

Also known as: segmental resection
Level III

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Those patients with locally advanced tumors that were not responded to neoadjuvant therapy were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

MastectomySurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof

Study Record Dates

First Submitted

May 31, 2020

First Posted

June 4, 2020

Study Start

May 1, 2014

Primary Completion

October 1, 2018

Study Completion

May 1, 2019

Last Updated

May 11, 2022

Record last verified: 2022-04