Usefulness of the Artery First Approach in Pancreatic Cancer Surgery

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Procedure: conventional pancreaticoduodenectomy
* Procedure: total mesopancreas excision including superior mesenteric artery first approach


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional<br>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. | Procedure: conventional pancreaticoduodenectomy<br>* 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.<br>|
| Experimental: total mesopancreas excision with arterial first approach<br>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. | Procedure: total mesopancreas excision including superior mesenteric artery first approach<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2 years recurrence free survival | locoregional or systemic tumor recurrence after surgery within 2 years | 2 years after surgery | 

Secondary Outcome Measures

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