Extended Pancreatic Transection Versus Conventional Pancreatic Transection During Laparoscopic Pancreaticoduodenectomy

Not yet recruiting

• Conditions: Laparoscopic Pancreaticoduodenectomy
• Interventions: Procedure: extended pancreatic transection during laparoscopic pancreaticoduodenectomy

• Registration Number: NCT05905549
• Lead Sponsor: Xinrui Zhu，MD

Brief Summary

The level of pancreatic neck transection during laparoscopic pancreaticoduodenectomy (LPD) is not conclusive. Theoretically, the level of pancreatic transection can significantly affect the occurrence of postoperative pancreatic fistula (POPF) by influencing both the blood supply to the anastomosis and the location of the main pancreatic duct in the pancreatic transverse section. The investigators conduct a retropective propensity score-matched comparison to compare the impact of extended pancreatic transection and conventional pancreatic transection on POPF and the performance of the pancreaticojejunostomy during LPD.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-05
• Study First Submitted QC: 2023-06-07
• Study First Posted: 2023-06-15
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-15
• Last Update Posted: 2023-07-18
• Study Start: 2023-08-01
• Primary Completion: 2023-12-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

1. consecutive patients underwent elective laparoscopic pancreaticoduodenectomy within October 2019 to April 2023
2. the perioperative and follow-up study data information can be collected completely
3. The level of pancreatic neck dissection can be determined by postoperative abdominal CT
4. patients without the history of neoadjuvant chemotherapy or radiotherapy

Exclusion Criteria

1. conversion to laparotomy due to various reasons during operation;
2. combined with resection and reconstruction of the portal vein or the superior mesenteric vein
3. combined with other organ resection
4. the perioperative and follow-up study data information can not be collected completely, or the level of pancreatic neck dissection can not be determined by postoperative abdominal CT
5. patients with the history of neoadjuvant chemotherapy or radiotherapy
6. the main pancreatic duct did not be found during the operation, the duct-to-mucosa pancreaticojejunostomy could not be performed

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
extended pancreatic transection cohort	extended pancreatic transection during laparoscopic pancreaticoduodenectomy	cases in which the pancreatic transection was performed at the pancreatic neck beyond the left side of the mesenterico-portal axis during laparoscopic pancreaticoduodenectomy, as judged by postoperative abdominal CT scan.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
surgical performance of pancreaticojejunostomy	intraoperatively	the duration of pancreaticojejunostomy
postoperative mortality	3 months postoperatively	mortality within 3 months postoperatively
postoperative morbidity	3 months postoperatively	postoperative morbidity (Clavien-Dindo score ≥3) within 3 months postoperatively