Usefulness of the Artery First Approach in Pancreatic Cancer Surgery

Not Applicable

• Conditions: Margin, Tumor-Free; Recurrence Tumor; Pancreatic Cancer, Adult; Surgery Site Fistula
• Interventions: Procedure: total mesopancreas excision including superior mesenteric artery first approach; Procedure: conventional pancreaticoduodenectomy

• Registration Number: NCT04136522
• Lead Sponsor: Asan Medical Center

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.

Study Timeline

• Study First Submitted: 2019-10-21
• Study First Submitted QC: 2019-10-21
• Study First Posted: 2019-10-23
• Study Start: 2020-01-10
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-20
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 268

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

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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.)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
total mesopancreas excision with arterial first approach	total mesopancreas excision including superior mesenteric artery 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.
conventional	conventional pancreaticoduodenectomy	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Asan medical center; 🇰🇷 Seoul, Korea, Republic of