Usefulness of the Artery First Approach in Pancreatic Cancer Surgery

NCT04136522 — Not applicable, Unknown, 268 participants, Asan Medical Center

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

Registry	NCT04136522
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	268 (Estimated)
Sponsor	Asan Medical Center (Other)
Conditions	Pancreatic Cancer, Adult, Margin, Tumor-Free, Surgery Site Fistula, Recurrence Tumor
Interventions	conventional pancreaticoduodenectomy, total mesopancreas excision including superior mesenteric artery first approach (Procedure)
Dates	start 2020-01-10, primary completion 2023-12-31 (estimated), completion 2023-12-31 (estimated), first posted 2019-10-23, last updated 2022-07-20
Locations	1 site in South Korea

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
conventional	Active comparator	Procedure: 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.
total mesopancreas excision with arterial first approach	Experimental	Procedure: 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 pancreaticoduodenectomy (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 including superior mesenteric artery first approach (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.

+Outcome measures

Primary outcomes

2 years recurrence free survival [2 years after surgery]: locoregional or systemic tumor recurrence after surgery within 2 years

Secondary outcomes

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

+Eligibility

Sex: All, ages: 20 Years to any, accepts healthy volunteers

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.)

+Locations (1)

Facility	City	Country	Status
Asan medical center	Seoul	South Korea	Recruiting

+Investigators

Song-Cheol Kim, MD.PhD, Principal investigator, Asan Medical Center