Comparison of Perioperative Outcomes Between Laparoscopic and Open Pylorus Preserving Pancreaticoduodenectomy in Periampullary Tumors: Randomized Controlled Study

• Pancreatoduodenectomy is a standard procedure for periampullary disease of the duodenum (pancreatic cancer, biliary pancreatic cancer, bile duct cancer, etc.) and is a very extensive and complicated operation for partial resection of the pancreas, duodenum, bile duct, gallbladder and occasionally stomach. In addition, anastomotic anastomoses are considered to be one of the most complicated surgeries among intraperitoneal procedures, even in open surgery. Laparoscopic surgery has been advancing rapidly with the development of the technique of laparoscopic surgery. In recent years, Pancreatoduodenectomy has been actively attempting laparoscopic surgery centering on large organs. As a result, large incision and abdominal wall traction can be avoided. Common advantages include postoperative pain relief, rapid recovery of bowel movements, fewer days of hospitalization, and a quick return to daily life. In addition, recently reported meta-analysis has shown that laparoscopic Pancreatoduodenectomy has a significantly lower bleeding volume and duration of hospitalization compared to open surgery.
• This study was aimed to compared functional recovery between open and laparoscopic PD in 3 tertiary referral centers in Korea. The investigators will measure functional recovery .
• A case of pancreaticoduodenectomy with benign tumor in the pancreas will be included. The expected number of patients is 252. The laparoscopic surgery was performed in the experimental group and the open surgery was performed in the control group. When achieving 50% of the planned target group, the interim analysis will decide whether to continue the study.

This clinical study is a randomized prospective comparative study of the outcome of laparoscopic and open Pancreatoduodenectomy, and the research hypothesis is as follows.

• Nursing Hypothesis: There is no difference in the functional recovery between patients who underwent laparoscopic pancreaticoduodenectomy and patients who underwent open surgery.
• Alternative Hypothesis: Based on the results of the same operation of the existing institution, the average functional recovery for open pancreaticoduodenectomy is estimated to be 14 days, and the functional recovery for laparoscopic pancreaticoduodenectomy is reduced by 20%.

The random assignment of this study is assigned according to the order of assignment in the planning stage of the study as a block randomization scheme with appropriate block size set.

• Plan for recruitment of research subjects All patients who underwent pancreaticoduodenectomy for the pancreas or peripapillary lesion were selected and selected as subjects after explaining the study and accepting consent.
• Operative methods Both patients underwent conventional pancreaticoduodenectomy or pyloric preservation pancreaticoduodenectomy. In the control group, the midline incision was performed and the operation was performed by the laparotomy. In the experimental group, laparoscopic surgery was performed using 5-6 trocars. Laparoscopy and laparotomy are performed through the same surgical procedure and the procedure is as follows. Kocher maneuver is performed to mobilize the duodenum.