Usefulness of the Artery First Approach in Pancreatic Cancer Surgery

NCT ID: NCT04136522

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 268 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-10
• Study Completion Date: 2023-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

conventional pancreaticoduodenectomy

Intervention Type: PROCEDURE

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 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.

Group Type: EXPERIMENTAL

total mesopancreas excision including superior mesenteric artery first approach

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.)

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Song Cheol Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Song-Cheol Kim, MD.PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan medical center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Woohyung Lee, MD.

Role: CONTACT

ywhnet@gmail.com

+82-02-3010-3993

Facility Contacts

Woohyung Lee, MD

Role: primary

Other Identifiers

SMATME

Identifier Type: -

Identifier Source: org_study_id