Laparoscopic Pancreaticoduodenectomy
Conditions
Keywords
laparoscopic pancreaticoduodenectomy, pancreatic neck transection level
Brief summary
The investigators conduct the clinical randomized controlled trial to evaluate the superiority of extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy (LPD). The participants in the study group obtain extended pancreatic neck transection during LPD, while participants in the control group conventional pancreatic neck transection. The purposes of this study include: 1.Primary objective: To compare the incidence of clinically relevant pancreatic fistula (grades B-C according International Study Group on Pancreatic Surgery) between the study group and the control group. 2.Secondary objective: To compare the incidence of postoperative morbidity (Clavien-Dindo score ≥3）between the two groups. To compare the location of pancreatic duct and the surgical performance of pancreaticojejunostomy between the two groups.
Interventions
PROCEDUREextended pancreatic neck transection during laparoscopic pancreaticoduodenectomy
Transect the pancreatic neck at ≥5mm and ≤10mm beyond the left side of the portal vein.
Sponsors
The Affiliated Hospital Of Guizhou Medical University
Shandong Provincial Hospital
Qilu Hospital of Shandong University
Xinrui Zhu，MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with benign or resectable malignant tumors of the lower common bile duct, Vater ampulla, head or uncinate process of the pancreas. 2. 18 years old \< age \< 80 years old, no gender limit. 3. Patient is expected survival beyond 3 months. 4. No pregnancy or pregnancy plan within 3 months after surgery. 5. Nutrition risk score \<3 according to the Nutritional Risk Screening for Inpatients 2002 (NRS2002) standard score. 6. No contraindication to surgery for anesthetic evaluation. 7. The subjects voluntarily joined the study and signed an informed consent form, with good compliance and cooperation with follow-up.
Exclusion criteria
1. Patients with borderline resectable and unresectable malignancies. 2. Patients undergoing neoadjuvant chemotherapy or radiotherapy. 3. Patients with tumors exceeding the level of the gastroduodenal artery as measured by preoperative radiography. 4. Intraoperative exploration reveals tumor adhesions with portal vein-superior mesenteric vein, requiring revascularization and reconstruction. 5. Operation transfers to open. 6. Operation transfers to other procedure. 7. The main pancreatic duct can not be found intraoperatively, the duct-to-mucosa pancreaticojejunostomy can not be operated.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the incidence of clinically relevant pancreatic fistula | 3 months postoperatively | the incidence of the clinically relevant pancreatic fistula according the International Study Group of Pancreatic Surgery's definition and grading |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| location of the pancreatic duct in the pancreatic transverse section | intraoperatively | Before performing the pancreaticojejunostomy, place the pancreatic transverse section in the central position of the lens. Measure the anterior-posterior diameter of the pancreas and the distance of the pancreatic duct from the back of the pancreas. The location of the pancreatic duct in the pancreatic transverse section is equal to the ratio of the distance of the pancreatic duct from the back of the pancreas to the anterior-posterior diameter of the pancreas. |
| surgical performance of pancreaticojejunostomy | intraoperatively | the duration of pancreaticojejunostomy |
| postoperative morbidity | 3 months postoperatively | postoperative morbidity (Clavien-Dindo score ≥3）within 3 months postoperatively |
| postoperative mortality | 3 months postoperatively | mortality within 3 months postoperatively |
Countries
China
Contacts
Primary ContactBing Peng
Backup ContactYunqiang Cai
Outcome results
None listed