Usefulness of the Artery First Approach in Pancreatic Cancer Surgery

July 18, 2022 updated by: Song Cheol Kim, Asan Medical Center

A Prospective Randomized Study of the Usefulness of the Artery First Approach in Pancreatic Cancer With Pancreaticoduodenectomy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The patients will be divided into 2 groups

conventional group: 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.

Experimental group:

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.

Postoperative manage is same in two groups. The investigators will compared 2 years recurrence free survival rate between conventional and experimental groups.

Study Type

Interventional

Enrollment (Anticipated)

268

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Woohyung Lee, MD.
  • Phone Number: +82-02-3010-3993
  • Email: ywhnet@gmail.com

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center
        • Contact:
          • Woohyung Lee, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: conventional
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
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.
EXPERIMENTAL: total mesopancreas excision with arterial first approach
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2 years recurrence free survival
Time Frame: 2 years after surgery
locoregional or systemic tumor recurrence after surgery within 2 years
2 years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
R0 resection
Time Frame: 7-10 days after surgery
Microscopic tumor clearance after surgery in pathologic result
7-10 days after surgery
Recurrence pattern
Time Frame: 2 years after surgery
locoregional recurrence: around SMA, celiac axis, remnant pancreas, systemic recurrence: liver, lung, bone
2 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Song-Cheol Kim, MD.PhD, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 10, 2020

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

October 21, 2019

First Submitted That Met QC Criteria

October 21, 2019

First Posted (ACTUAL)

October 23, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMATME

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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