NCT04136522

Brief Summary

This study is aimed to evaluate difference of the 2 year recurrence free survival after pancreaticoduodenectomy for pancreatic cancer between artery-first approach and conventional procedure groups.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
268

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 21, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 10, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

4 years

First QC Date

October 21, 2019

Last Update Submit

July 18, 2022

Conditions

Pancreatic Cancer, AdultMargin, Tumor-FreeSurgery Site FistulaRecurrence Tumor

Outcome Measures

Primary Outcomes (1)

  • 2 years recurrence free survival

    locoregional or systemic tumor recurrence after surgery within 2 years

    2 years after surgery

Secondary Outcomes (2)

  • R0 resection

    7-10 days after surgery

  • Recurrence pattern

    2 years after surgery

Study Arms (2)

conventional

ACTIVE COMPARATOR

The patients who included this group will undergo conventional pancreaticoduodenectomy (PD) or pylorus preserving pancreaticoduodenectomy (PPPD). We will identify and isolate superior mesenteric vein (SMV) before pancreatic resection. The surgeon will dissect tissue around superior mesenteric artery (SMA) and uncinate process of pancreas along the SMA.

Procedure: conventional pancreaticoduodenectomy

total mesopancreas excision with arterial first approach

EXPERIMENTAL

The patients who included this group will undergo PD or PPPD including total pancreatic mesopancreas excision and superior mesenteric artery approach. Before pancreatic transection, the surgeon will isolate superior mesenteric vein (SMV) and superior mesenteric artery (SMA). And the surgeon will dissect nerve plexus and lymph node around SMA. inferior pancreaticoduodenal artery (IPDA) and first jejunal artery will be identified and the surgeon will ligate according to surgical margin. Anastomosis will be performed as usual manners.

Procedure: total mesopancreas excision including superior mesenteric artery first approach

Interventions

conventional pancreaticoduodenectomyPROCEDURE

In this subgroup, the surgeon will perform pancreaticoduodenectomy without isolation of superior mesenteric artery and dissection of nerve plexus and lymph node around superior mesenteric artery.

conventional
total mesopancreas excision including superior mesenteric artery first approachPROCEDURE

In this subgroup, the surgeon will identify and isolate superior mesenteric artery before pancreatic transection, they dissect soft tissues including nerve plexus and node around superior mesenteric artery.

total mesopancreas excision with arterial first approach

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Resectable pancreatic head cancer
  • No systemic metastasis
  • Age \> 20 years
  • The patients who understand informed consent and is able to agree with study

You may not qualify if:

  • The patients who have systemic metastasis
  • The patients who need neoadjuvant therapy in borderline resectable and locally advanced pancreatic cancer
  • Those with active or uncontrolled infections
  • Those with severe psychiatric / neurological disorders
  • Alcohol or other drug addicts
  • Patients with moderate or severe comorbidities who are thought to have an impact on quality of life or nutritional status (cirrhosis, chronic kidney failure, heart failure, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan medical center

Seoul, 05505, South Korea

RECRUITING

MeSH Terms

Conditions

Pancreatic cancer, adultMargins of ExcisionRecurrence

Condition Hierarchy (Ancestors)

Morphological and Microscopic FindingsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Officials

  • Song-Cheol Kim, MD.PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Woohyung Lee, MD.

CONTACT

+82-02-3010-3993ywhnet@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 21, 2019

First Posted

October 23, 2019

Study Start

January 10, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

July 20, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)