Extended Pancreatic Neck Transection Versus Conventional Pancreatic Neck Transection During Laparoscopic Pancreaticoduodenectomy( LPDEXCEPT)

Laparoscopic Pancreaticoduodenectomy Clinical Trial

— LPDEXCEPT  

Official title:

Extended Pancreatic Neck Transection Versus Conventional Pancreatic Neck Transection During Laparoscopic Pancreaticoduodenectomy( LPDEXCEPT): a Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05808894
• Other study ID #: 2023-167-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2023
• Est. completion date: June 2026

Study information

• Verified date: July 2023
• Source: West China Hospital
• Contact: Bing Peng
• Phone: +862862539242
• Email: pengbing84[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 154
• Est. completion date: June 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Laparoscopic Pancreaticoduodenectomy

Intervention

Procedure:
• extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy
Transect the pancreatic neck at =5mm and =10mm beyond the left side of the portal vein.

Locations

Country	Name	City	State
China	West China Hospital of Sichuan University	Chengdu	Sichuan

Sponsors (4)

Lead Sponsor	Collaborator
Xinrui Zhu,MD	Qilu Hospital of Shandong University, Shandong Provincial Hospital, The Affiliated Hospital Of Guizhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.	intraoperatively
Secondary	surgical performance of pancreaticojejunostomy	the duration of pancreaticojejunostomy	intraoperatively
Secondary	postoperative morbidity	postoperative morbidity (Clavien-Dindo score =3)within 3 months postoperatively	3 months postoperatively
Secondary	postoperative mortality	mortality within 3 months postoperatively	3 months postoperatively