Extended Pancreatic Neck Transection Versus Conventional Pancreatic Neck Transection During Laparoscopic Pancreaticoduodenectomy( LPDEXCEPT)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: extended transection group the patients in extended transection group obtain extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy. |
Procedure: extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy
Transect the pancreatic neck at ≥5mm and ≤10mm beyond the left side of the portal vein.
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| No Intervention: conventional transection group the patients in conventional transection group obtain conventional pancreatic neck transection during laparoscopic pancreaticoduodenectomy. |
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with benign or resectable malignant tumors of the lower common bile duct, Vater ampulla, head or uncinate process of the pancreas.
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18 years old < age < 80 years old, no gender limit.
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Patient is expected survival beyond 3 months.
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No pregnancy or pregnancy plan within 3 months after surgery.
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Nutrition risk score <3 according to the Nutritional Risk Screening for Inpatients 2002 (NRS2002) standard score.
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No contraindication to surgery for anesthetic evaluation.
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The subjects voluntarily joined the study and signed an informed consent form, with good compliance and cooperation with follow-up.
Exclusion Criteria:
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Patients with borderline resectable and unresectable malignancies.
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Patients undergoing neoadjuvant chemotherapy or radiotherapy.
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Patients with tumors exceeding the level of the gastroduodenal artery as measured by preoperative radiography.
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Intraoperative exploration reveals tumor adhesions with portal vein-superior mesenteric vein, requiring revascularization and reconstruction.
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Operation transfers to open.
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Operation transfers to other procedure.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | West China Hospital of Sichuan University | Chengdu | Sichuan | China | 610041 |
Sponsors and Collaborators
- Xinrui Zhu，MD
- Affiliated Hospital of Guizhou Medical University
- Panzhihua Central Hospital
- Shandong Provincial Hospital
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Leshan People's Hospital
- First People's Hospital of Yunnan Province
- Changzhou First People's Hospital
- Qilu Hospital of Shandong University
- Southern Hospital
- Cancer Hospital of Fudan University
Investigators
- Study Chair: Bing Peng, Professor, West China Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 2023-167-1