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

NCT05808894 | Not Yet Recruiting

• 1 other identifier: 2023-167-1
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Pancreaticoduodenectomy

Keywords

laparoscopic pancreaticoduodenectomy; pancreatic neck transection level

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• location of the pancreatic duct in the pancreatic transverse section

  intraoperatively

• surgical performance of pancreaticojejunostomy

  intraoperatively

• postoperative morbidity

  3 months postoperatively

• postoperative mortality

  3 months postoperatively

Study Arms (2)

extended transection group

EXPERIMENTAL

the patients in extended transection group obtain extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy.

Procedure: 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.

Interventions

extended pancreatic neck transection during laparoscopic pancreaticoduodenectomy PROCEDURE

Transect the pancreatic neck at ≥5mm and ≤10mm beyond the left side of the portal vein.

extended transection group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with benign or resectable malignant tumors of the lower common bile duct, Vater ampulla, head or uncinate process of the pancreas.
• years old \< age \< 80 years old, no gender limit.
• Patient is expected survival beyond 3 months.
• No pregnancy or pregnancy plan within 3 months after surgery.
• Nutrition risk score \<3 according to the Nutritional Risk Screening for Inpatients 2002 (NRS2002) standard score.
• No contraindication to surgery for anesthetic evaluation.
• The subjects voluntarily joined the study and signed an informed consent form, with good compliance and cooperation with follow-up.

You may not qualify if:

• Patients with borderline resectable and unresectable malignancies.
• Patients undergoing neoadjuvant chemotherapy or radiotherapy.
• Patients with tumors exceeding the level of the gastroduodenal artery as measured by preoperative radiography.
• Intraoperative exploration reveals tumor adhesions with portal vein-superior mesenteric vein, requiring revascularization and reconstruction.
• Operation transfers to open.
• Operation transfers to other procedure.
• The main pancreatic duct can not be found intraoperatively, the duct-to-mucosa pancreaticojejunostomy can not be operated.

Sponsors & Collaborators

• Xinrui Zhu，MD: lead
• The Affiliated Hospital Of Guizhou Medical University: collaborator
• Shandong Provincial Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

Related Publications (5)

• 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.

  PMID: 32841726 BACKGROUND

• 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.

  PMID: 28990000 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.

  PMID: 12081065 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.

  PMID: 26160766 BACKGROUND

• 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.

  PMID: 38199635 DERIVED

Study Officials

• Bing Peng, Professor

  West China Hospital

  STUDY CHAIR

Central Study Contacts

Bing Peng

CONTACT

+862862539242; pengbing84@hotmail.com

Yunqiang Cai

CONTACT

yunqiangcaiwch@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: attending doctor

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 12, 2023
• Study Start: August 1, 2023
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)