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Usefulness of the Artery First Approach in Pancreatic Cancer Surgery

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
conventional pancreaticoduodenectomy
total mesopancreas excision including superior mesenteric artery first approach
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer, Adult

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.)

Sites / Locations

  • Asan medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

conventional

total mesopancreas excision with arterial first approach

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

2 years recurrence free survival
locoregional or systemic tumor recurrence after surgery within 2 years

Secondary Outcome Measures

R0 resection
Microscopic tumor clearance after surgery in pathologic result
Recurrence pattern
locoregional recurrence: around SMA, celiac axis, remnant pancreas, systemic recurrence: liver, lung, bone

Full Information

First Posted
October 21, 2019
Last Updated
July 18, 2022
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04136522
Brief Title
Usefulness of the Artery First Approach in Pancreatic Cancer Surgery
Official Title
A Prospective Randomized Study of the Usefulness of the Artery First Approach in Pancreatic Cancer With Pancreaticoduodenectomy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Adult, Margin, Tumor-Free, Surgery Site Fistula, Recurrence Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
268 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conventional
Arm Type
Active Comparator
Arm Description
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.
Arm Title
total mesopancreas excision with arterial first approach
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
conventional pancreaticoduodenectomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
total mesopancreas excision including superior mesenteric artery first approach
Intervention Description
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 Measure Information:
Title
2 years recurrence free survival
Description
locoregional or systemic tumor recurrence after surgery within 2 years
Time Frame
2 years after surgery
Secondary Outcome Measure Information:
Title
R0 resection
Description
Microscopic tumor clearance after surgery in pathologic result
Time Frame
7-10 days after surgery
Title
Recurrence pattern
Description
locoregional recurrence: around SMA, celiac axis, remnant pancreas, systemic recurrence: liver, lung, bone
Time Frame
2 years after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Woohyung Lee, MD.
Phone
+82-02-3010-3993
Email
ywhnet@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Song-Cheol Kim, MD.PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan medical center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Woohyung Lee, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Usefulness of the Artery First Approach in Pancreatic Cancer Surgery

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