Status Approved
First Submitted Date
2021/03/12
Registered Date
2021/04/09
Last Updated Date
2022/12/19
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0006074 |
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Unique Protocol ID | 2021-0138 |
Public/Brief Title | Comparison of pancreatic fistula according to clip on staple line during laparoscopic distal pancreatectomy for pancreatic tumor: A randomized controlled prospective study |
Scientific Title | Comparison of pancreatic fistula according to clip on staple line during laparoscopic distal pancreatectomy for pancreatic tumor: A randomized controlled prospective study |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Submitted approval |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | 2021-0138 |
Approval Date | 2021-01-29 |
Institutional Review Board Name | Asan Medical Center Institutional Review Board |
Institutional Review Board Address | 88, Olympic-ro 43-gil, Songpa-gu, Seoul |
Institutional Review Board Telephone | 02-3010-7166 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | song cheol Kim |
Title | M.D |
Telephone | +82-2-3010-3936 |
Affiliation | Asan Medical Center |
Address | 88, Olympic-ro 43-gil, Songpa-gu, Seoul |
Contact Person for Public Queries | |
Name | song cheol Kim |
Title | M.D |
Telephone | +82-2-3010-3936 |
Affiliation | Asan Medical Center |
Address | 88, Olympic-ro 43-gil, Songpa-gu, Seoul |
Contact Person for Updating Information | |
Name | seo hyun Kim |
Title | CRC |
Telephone | +82-2-3010-8667 |
Affiliation | Asan Medical Center |
Address | 88, Olympic-ro 43-gil, Songpa-gu, Seoul |
4. Status
Study Site | Multi-center Number of center : 3 | |
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Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-06-24 Actual | |
Target Number of Participant | 190 | |
Primary Completion Date | 2024-12-31 , Anticipated | |
Study Completion Date | 2024-12-31 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Asan Medical Center | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-06-24 , | |
Recruitment Status by Participating Study Site 2 | ||
Name of Study | Samsung Medical Center | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2022-05-17 , | |
Recruitment Status by Participating Study Site 3 | ||
Name of Study | Kangbuk Samsung Medical Center | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2022-11-07 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Asan Medical Center |
Organization Type | Medical Institute |
Project ID | 2021-0138 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Asan Medical Center |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | 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 |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Others (This study is aimed to compare postoperative pancreatic fistula between reinforcement and non-reinforcement after laparoscopic distal pancreatectomy in patients) |
Phase | Not applicable |
Intervention Model | Parallel |
Blinding/Masking | Single |
Blinded Subject | Subject |
Allocation | RCT |
Intervention Type | /Procedure/Surgery |
Intervention Description | 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. |
Number of Arms | 2 |
Arm 1 |
Arm Label Experiment |
Target Number of Participant 95 |
|
Arm Type Experimental |
|
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 2 |
Arm Label Control |
Target Number of Participant 95 |
|
Arm Type No intervention |
|
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. |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (C00-D48)Neoplasms (C25.9)Malignant neoplasm of pancreas, unspecified The patients who need laparoscopic distal pancreatectomy for pancreatic neoplasm of tail portion. |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 18Year~79Year |
|
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 |
|
Exclusion Criteria |
- 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 |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Not applicable | |
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Primary Outcome(s) 1 | ||
Outcome | Postoperative pancreatic fistula grade B or more |
|
Timepoint | 90 days after operation |
|
Secondary Outcome(s) 1 | ||
Outcome | Operative time |
|
Timepoint | 90 days after operation |
|
Secondary Outcome(s) 2 | ||
Outcome | Estimated blood loss |
|
Timepoint | 90 days after operation |
|
Secondary Outcome(s) 3 | ||
Outcome | Posoperative complication |
|
Timepoint | 90 days after operation |
|
Secondary Outcome(s) 4 | ||
Outcome | Postoperative laborative finding |
|
Timepoint | 90 days after operation |
|
Secondary Outcome(s) 5 | ||
Outcome | Hospital stay |
|
Timepoint | 90 days after operation |
|
Secondary Outcome(s) 6 | ||
Outcome | comparison pathology finding |
|
Timepoint | 90 days after operation |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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