Extended Pancreatic Transection Versus Conventional Pancreatic Transection During Laparoscopic Pancreaticoduodenectomy

Sponsor
Xinrui Zhu,MD (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05905549
Collaborator
(none)
184
12

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: extended pancreatic transection during laparoscopic pancreaticoduodenectomy

Study Design

Study Type:
Observational
Anticipated Enrollment :
184 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Extended Pancreatic Transection Versus Conventional Pancreatic Transection During Laparoscopic Pancreaticoduodenectomy: a Retrospective Propensity Score-matched Comparison
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
extended pancreatic transection cohort

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.

Procedure: extended pancreatic transection during laparoscopic pancreaticoduodenectomy
the pancreatic transection was performed at the pancreatic neck beyond the left side of the mesenterico-portal axis during laparoscopic pancreaticoduodenectomy

conventional pancreatic transection cohort

cases in which the pancreatic transection was performed at the pancreatic neck above the mesenterico-portal axis during laparoscopic pancreaticoduodenectomy, as judged by postoperative abdominal CT scan.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. surgical performance of pancreaticojejunostomy [intraoperatively]

    the duration of pancreaticojejunostomy

  2. postoperative morbidity [3 months postoperatively]

    postoperative morbidity (Clavien-Dindo score ≥3) within 3 months postoperatively

  3. postoperative mortality [3 months postoperatively]

    mortality within 3 months postoperatively

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Xinrui Zhu,MD

Investigators

  • Study Chair: Bing Peng, West China Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Xinrui Zhu,MD, attending doctor, West China Hospital
ClinicalTrials.gov Identifier:
NCT05905549
Other Study ID Numbers:
  • 2023-167-2
First Posted:
Jun 15, 2023
Last Update Posted:
Jun 15, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Xinrui Zhu,MD, attending doctor, West China Hospital

Study Results

No Results Posted as of Jun 15, 2023