Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Seoul National University Bundang Hospital | OTHER |
| Severance Hospital | OTHER |
| Samsung Medical Center | OTHER |
| Hallym University Medical Center |
Not provided
Not provided
Not provided
Not provided
Laparoscopic surgery has not changed much in safety compared with open surgery through many existing studies, and has become a procedure to help patients' recovery.
Recently, laparoscopic surgery has been actively performed for pancreaticoduodenectomy, one of the most complicated procedures in intraperitoneal surgery.
the investigators will perform a prospective study to establish a higher level of evidence for the efficacy and safety of laparoscopic pancreaticoduodenectomy.
The purpose of this study was to compare the short-term clinical outcomes including the functional recovery after surgery, complications and confirm that laparoscopic pancreaticoduodenectomy is safe and appropriate. This study includes an interim analysis and can be terminated early by analysis at the completion of 50% of planned patients.
This clinical study is a randomized prospective comparative study of the outcome of laparoscopic and open Pancreatoduodenectomy, and the research hypothesis is as follows.
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.
Omentectomy is performed and the gastrocolic truck is identified and ligated. The stomach or duodenum is cut off using an automatic stapler. A cholecystectomy is performed. The bile duct is cut and the frozen section is checked to confirm whether the tumor is invaded. The hepatic and hepatic arteries are dissected and the surrounding lymph nodes are dissected. The gastroduodenal artery is detached and ligated. The pancreas is cut from the pancreas neck, and the tumor is examined by freezing biopsy. The proximal plant is dissected and cut, and the pancreas uncinate process is released from the superior mesenteric artery and vein. Pancreaticojejunal anastomosis, hepaticojejunal anastomosis, gastrojejunal or duodenojejunal anastomosis are performed. In this case, anastomosis is performed by the method used by each institution.
Indications for open conversion
Patient management after surgery.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic group | Experimental | The patients who underwent laparoscopic procedures for periampullary tumors |
|
| Open group | No Intervention | The patients who underwent open procedures for periampullary tumors |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic group | Procedure | The patients in laparoscopic group will underwent pylorus preserving pancreaticoduodenectomy in laparoscopic manners. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to functional recovery after surgery | It is defined that functional recovery is achieved if all of the following are satisfied. 1. Pain can be controlled by oral or patch analgesic without intravenous analgesics. * 2. Free walking (modified enhanced recovery after surgery mobility scale 5/5) ** 3. Free diet is available (more than 1/2 of the dietary intake) 4. No evidence of infection (body temperature <38.5 degrees, C-reactive protein (CRP) 15 mg / dL, no complicated fluid collection on postoperative computed tomography 5. There should be no intravenous injection . | up to 1 months |
| Measure | Description | Time Frame |
|---|---|---|
| Numbers of Hospital stay | It is defined that discharge day after surgery | up to 2 months |
| Minutes of operation time | It mean time from anesthesia to end of surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Song-Cheol Kim, MD, PhD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan medical center | Seoul | 05505 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39172725 | Derived | Yoon YS, Lee W, Kang CM, Hong T, Shin SH, Lee JW, Hwang DW, Song KB, Kwon JW, Sung MK, Shim IK, Lee JB, Kim SC; for Korean Study Group on Minimally Invasive Pancreatic Surgery (K-MIPS). Laparoscopic versus open pancreatoduodenectomy for periampullary tumors: a randomized clinical trial. Int J Surg. 2024 Nov 1;110(11):7011-7019. doi: 10.1097/JS9.0000000000002035. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to 1 day after surgery |
| amount of estimated blood loss | It means amount of bleeding during surgery | up to 1 day after surgery |
| Severity of postoperative pain | It refers to the degree of pain measured during 2 days after surgery | Up to 3 days |
| postoperative complications | It means all kinds of complications after surgery | up to 2 months |
| Numbers of complete resection in pathological results | It means no remnant tumor in pathologic results | Up to 2weeks |
| level of serum cytokine | It means value of serum cytokine, which was collected after surgery | Up to 1 week |