Margin, Tumor-Free, Pancreatic Cancer, Adult, Recurrence Tumor, Surgery Site Fistula
Conditions
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.
Interventions
PROCEDUREconventional 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.
PROCEDUREtotal 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.
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2 years recurrence free survival | 2 years after surgery | locoregional or systemic tumor recurrence after surgery within 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| R0 resection | 7-10 days after surgery | Microscopic tumor clearance after surgery in pathologic result |
| Recurrence pattern | 2 years after surgery | locoregional recurrence: around SMA, celiac axis, remnant pancreas, systemic recurrence: liver, lung, bone |
Countries
South Korea
Contacts
Primary ContactWoohyung Lee, MD.
Outcome results
None listed