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| Name | Class |
|---|---|
| The Affiliated Hospital Of Guizhou Medical University | OTHER |
| Shandong Provincial Hospital | OTHER_GOV |
| Qilu Hospital of Shandong University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| extended transection group | Experimental | the patients in extended transection group obtain extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy. |
|
| conventional transection group | No Intervention | the patients in conventional transection group obtain conventional pancreatic neck transection during laparoscopic pancreaticoduodenectomy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy | Procedure | Transect the pancreatic neck at ≥5mm and ≤10mm beyond the left side of the portal vein. |
| Measure | Description | Time Frame |
|---|---|---|
| the incidence of clinically relevant pancreatic fistula | the incidence of the clinically relevant pancreatic fistula according the International Study Group of Pancreatic Surgery's definition and grading | 3 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| location of the pancreatic duct in the pancreatic transverse section | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bing Peng | Contact | +862862539242 | pengbing84@hotmail.com | |
| Yunqiang Cai | Contact | yunqiangcaiwch@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Bing Peng, Professor | West China Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32841726 | Background | Bardol T, Delicque J, Hermida M, Herrero A, Guiu B, Fabre JM, Souche R. Neck transection level and postoperative pancreatic fistula after pancreaticoduodenectomy: A retrospective cohort study of 195 patients. Int J Surg. 2020 Oct;82:43-50. doi: 10.1016/j.ijsu.2020.08.001. Epub 2020 Aug 22. | |
| 28990000 | Background |
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| intraoperatively |
| surgical performance of pancreaticojejunostomy | the duration of pancreaticojejunostomy | intraoperatively |
| postoperative morbidity | postoperative morbidity (Clavien-Dindo score ≥3）within 3 months postoperatively | 3 months postoperatively |
| postoperative mortality | mortality within 3 months postoperatively | 3 months postoperatively |
| Jwa EK, Hwang S. Extended pancreatic transection for secure pancreatic reconstruction during pancreaticoduodenectomy. Ann Hepatobiliary Pancreat Surg. 2017 Aug;21(3):138-145. doi: 10.14701/ahbps.2017.21.3.138. Epub 2017 Aug 31. |
| 12081065 | Background | Strasberg SM, Drebin JA, Mokadam NA, Green DW, Jones KL, Ehlers JP, Linehan D. Prospective trial of a blood supply-based technique of pancreaticojejunostomy: effect on anastomotic failure in the Whipple procedure. J Am Coll Surg. 2002 Jun;194(6):746-58; discussion 759-60. doi: 10.1016/s1072-7515(02)01202-4. |
| 26160766 | Background | Subar D, Pietrasz D, Fuks D, Gayet B. A novel technique for reducing pancreatic fistulas after pancreaticojejunostomy. J Surg Case Rep. 2015 Jul 9;2015(7):rjv074. doi: 10.1093/jscr/rjv074. |
| 38199635 | Derived | You J, Zhang J, Cai H, Wang X, Wang H, Li Y, Yu C, Wang L, Zhou X, Peng B, Cai Y. Extended pancreatic neck transection versus conventional pancreatic neck transection during laparoscopic pancreaticoduodenectomy (LPDEXCEPT): protocol for a multicentre superiority randomised controlled trial. BMJ Open. 2024 Jan 10;14(1):e078092. doi: 10.1136/bmjopen-2023-078092. |