1. Aim 
This study is aimed to compare postoperative pancreatic fistula between reinforcement and non-reinforcement after laparoscopic distal pancreatectomy in patients with pancreatic neoplasm and conclusion of this study may give answer for clinical guideline for laparoscopic distal pancreatectomy. 

2. Background 
Previous studies showed comparable safety of laparoscopic surgery compared with open srugery, and the patients with laparoscopy experienced early recovery compared with open surgery.
Although previous study showed the patients with reinforcement after lap DP showed lower posoperative pancreatic fistula, the role of reinforcement after laparoscopic distal pancreatectomy is unclear in currence guideline for minimally invasive pancreatice surgery. 
Therefore, we plan to compare postoperative pancreatic fistula according to the reinforcement using prospective randomized controlled study.

3. Hypothsis 
Null hypothesis: There were no significant difference of postoperative pancreatif fistula more than grade B between clip reinforcement and endo stapler only group.
Alternative Hypothesis: The patients with reinforcement of pancreatic resectiono margin show lower incidence of pacnreatic fistula compared with the patients who undergo endo stapler only.

(α value: 5%, (1-β) 80%): postoperative pancreatic fistular incidence in experiemental group and control group was 44.4% and 24.4%, respectively in previous study. To show positive result for alternative hypothesis with statistical significance, we need 95 patients in each group, Total patients are 190 considering 10% of spontaenous loss. 

4.Method
We perform randomization in patients who need laparoscopic distal pancreatectomy for pancreatic neoplasm of tail portion.
- Experiment: reinforcement after laparoscopic distal pancreatectomy 
- Control: non-reinforcement after laparoscopic distal pancreatectomy

Others

(This study is aimed to compare postoperative pancreatic fistula between reinforcement and non-reinforcement after laparoscopic distal pancreatectomy in patients)

This study was described for all patients scheduled for laparoscopic distal pancreatectomy  for pancreatic tail lesions after consenting process.
The randomization will be performed as 1:1 ratio, and both patient groups undergo common spleen preservation or pancreatic tailectomy including splenectomy.

The control group and the experimental group performed laparoscopic surgery using 5-6 trocars. The detailed operation procedure is as follows. After separating omentum and we confirm the lesion of the pancreas, the lower border of the pancreas is dissected, and the superior mesenteric vein and splenic vein are identified. After dissecting the upper margin of the pancreas, the pancreas neck is tunneled, and the pancreas is separated using an automatic suture above or to the left of the superior mesenteric vein according to the location of the tumor. In the case of the control group, sepration using endo stapler only and remnant surgery will be performed, and in the case of the experimental group, the transection line will be reinforced using a 5mm metal clip. Later, in the case of general pancreatic resection, the spleen vessels are excised, and the spleen is also excised. In the case of preservation of splenic vessels, the pancreatic parenchyma is removed while preserving the splenic arteries and veins, and in the case of the warshaw procedure, the splenic vessels are excised and separated by dissecting at the splenic hilum level. In the case of pancreatic cancer, lymph node around common hepatic artery and splenic vessel will be dissected and anterior radical antemodular pancreatosplenectomy are performed as needed. After placing the drain near the pancreatic resection surface, the operation is completed.

Arm Label

Target Number of Participant

Arm Type

Arm Description

After separating omentum and we confirm the lesion of the pancreas, the lower border of the pancreas is dissected, and the superior mesenteric vein and splenic vein are identified. After dissecting the upper margin of the pancreas, the pancreas neck is tunneled, and the pancreas is separated using an automatic suture above or to the left of the superior mesenteric vein according to the location of the tumor. In the case of the experimental group the transection line will be reinforced using a 5mm metal clip. Later, in the case of general pancreatic resection, the spleen vessels are excised, and the spleen is also excised. In the case of preservation of splenic vessels, the pancreatic parenchyma is removed while preserving the splenic arteries and veins, and in the case of the warshaw procedure, the splenic vessels are excised and separated by dissecting at the splenic hilum level. In the case of pancreatic cancer, lymph node around common hepatic artery and splenic vessel will be dissected and anterior radical antemodular pancreatosplenectomy are performed as needed. After placing the drain near the pancreatic resection surface, the operation is completed.

Arm Label

Target Number of Participant

Arm Type

Arm Description

After separating omentum and we confirm the lesion of the pancreas, the lower border of the pancreas is dissected, and the superior mesenteric vein and splenic vein are identified. After dissecting the upper margin of the pancreas, the pancreas neck is tunneled, and the pancreas is separated using an automatic suture above or to the left of the superior mesenteric vein according to the location of the tumor. In the case of the control group, sepration using endo stapler only and remnant surgery will be performed. Later, in the case of general pancreatic resection, the spleen vessels are excised, and the spleen is also excised. In the case of preservation of splenic vessels, the pancreatic parenchyma is removed while preserving the splenic arteries and veins, and in the case of the warshaw procedure, the splenic vessels are excised and separated by dissecting at the splenic hilum level. In the case of pancreatic cancer, lymph node around common hepatic artery and splenic vessel will be dissected and anterior radical antemodular pancreatosplenectomy are performed as needed. After placing the drain near the pancreatic resection surface, the operation is completed.

Gender

Age

Description

- Age more than 18, less than 80
- Performance status: ECOG 0-2
- pancreatic benign or malignant neoplasm in preoperative examination
- No distance metastasis
- Intact bone marrow function: WBC at least 3,000/mm3, Platelet count at least 100,000/mm3
- Intact renal function: Creatinine no greater than 1.5 times upper limit of normal
- Patients who can read and understand the informed consent and can express their intent to agree

- The patients with cctive and uncontrollable infection
- The patients with severe psychologic/neurologic disorder
- Alcoholics or drug addiction patient
- The patients who participated with other clinical studies
- Patients unable to comply with the researcher`s instruction
- The patients with moderate or severe underlying disease (liver cirrhosis, chronic renal failure, heart failure, COPD)
- The patients who need adjuntive organ resection including stomach, colon, and superior mesenteric vein 
- Unsuitable for research in the opinion of the researcher

Postoperative pancreatic fistula grade B or more

90 days after operation

Operative time

90 days after operation

Estimated blood loss

90 days after operation

Posoperative complication

90 days after operation

Postoperative laborative finding

90 days after operation

Hospital stay

90 days after operation

comparison pathology finding

90 days after operation