Usefulness Of The Artery First Approach In Pancreatic Cancer Surgery

Study Overview

Usefulness of the Artery First Approach in Pancreatic Cancer Surgery

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.

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.

Pancreatic Cancer, Adult
Margin, Tumor-Free
Surgery Site Fistula
Recurrence Tumor

PROCEDURE: conventional pancreaticoduodenectomy
PROCEDURE: total mesopancreas excision including superior mesenteric artery first approach

SMATME

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-10-21	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-07-18
First Submitted that Met QC Criteria 2019-10-21	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-07-20
First Posted (ACTUAL) 2019-10-23	Results First Posted N/A	Last Verified 2022-07

Study Plan

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

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 dis	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 mese	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.

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 dis

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 mese

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.

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

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

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:
1

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

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.)

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Song-Cheol Kim, MD.PhD, Asan Medical Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record