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NCT Number: NCT04416685

A New Anatomical Classification of Portal Vein Location of Pancreas Tumors

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

primary repair

Procedure

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.

segmental resection

Procedure

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.

Other names: primary repair

graft reconstruction

Procedure

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.

Other names: segmental resection

Primary outcomes

  1. peri-operative or postoperative complication

    Time frame: up to one month

    surgical complications observed during both operative and postoperative period

Secondary outcomes

  1. hospital stay

    Time frame: up to one month

    the time between the day of surgery and hospital discharge

Other outcomes

  1. in hospital mortality

    Time frame: up to two months

    any mortality after/during surgery in the initial hospital stay

Sponsors and collaborators

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Other

Registry information

Official study title

A New Anatomical Classification of Portal Venous Involvement in Locally Advanced Pancreatic Cancer to Predict the Surgical Difficulty

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Jun 4, 2020
Registry last updated
May 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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