Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03870698 |
| Other study ID # |
CORLAPPD_01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 9, 2019 |
| Est. completion date |
August 31, 2022 |
Study information
| Verified date |
February 2023 |
| Source |
Asan Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
- 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.
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
- In a situation where the safety of the patient is threatened, it is possible to switch
to the opener at any time under the judgment of the researcher.
- Vascular involvement of the superior mesenteric vein, superior mesenteric artery, and
hepatic artery is suspected and the operation is difficult to perform.
- The operation is difficult due to severe pancreatitis
- Laparoscopic treatment is difficult if there is bleeding
Patient management after surgery.
- 1 day after surgery: Removal of blood and nasogastric tube after surgery, water intake,
early gait, cytokine check
- 2 days after surgery: initiation or death, cytokine check
- 3 days after surgery: intravenous patient controlled analgesia removal, after 3 days,
considering drain amylase and drain volume can be removed. Check functional recovery
daily after 3 days
- 5 days after surgery: Perform computed tomography.
- 7 days after surgery: If the patient is a malignant tumor, the tumor marker will be
collected. Cytokine check
