A New Anatomical Classification of Portal Vein Location of Pancreas Tumors

Pancreatic Neoplasm Malignant Head Primary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04416685
• Other study ID #: PVR-2019
• Status: Completed
• Phase: N/A
• Start date: May 1, 2014
• Est. completion date: May 1, 2019

Study information

• Verified date: April 2022
• Source: Sisli Hamidiye Etfal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 1, 2019
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Pancreatic Neoplasm Malignant Head Primary
• Pancreatic Neoplasms

Intervention

Procedure:
• primary repair
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
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.
• graft reconstruction
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	in hospital mortality	any mortality after/during surgery in the initial hospital stay	up to two months
Primary	peri-operative or postoperative complication	surgical complications observed during both operative and postoperative period	up to one month
Secondary	hospital stay	the time between the day of surgery and hospital discharge	up to one month