Usefulness of the Artery First Approach in Pancreatic Cancer Surgery

Asan Medical Center268 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

268

Conditions

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

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.

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.

Eligibility

Sex: ALLMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.)

Locations (1)

Asan medical center

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

2 years recurrence free survival

locoregional or systemic tumor recurrence after surgery within 2 years

Time frame: 2 years after surgery

Secondary Outcomes

R0 resection

Microscopic tumor clearance after surgery in pathologic result

Time frame: 7-10 days after surgery

Recurrence pattern

locoregional recurrence: around SMA, celiac axis, remnant pancreas, systemic recurrence: liver, lung, bone

Time frame: 2 years after surgery

Central Contacts

Woohyung Lee, MD.

CONTACT

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

Data from ClinicalTrials.gov

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