Usefulness of the Artery First Approach in Pancreatic Cancer Surgery

Recurrence Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04136522
• Other study ID #: SMATME
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2022
• Source: Asan Medical Center
• Contact: Woohyung Lee, MD.
• Phone: +82-02-3010-3993
• Email: ywhnet[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 268
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Asan medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2 years recurrence free survival	locoregional or systemic tumor recurrence after surgery within 2 years	2 years after surgery
Secondary	R0 resection	Microscopic tumor clearance after surgery in pathologic result	7-10 days after surgery
Secondary	Recurrence pattern	locoregional recurrence: around SMA, celiac axis, remnant pancreas, systemic recurrence: liver, lung, bone	2 years after surgery