NCT05905549

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
184

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

July 18, 2023

Status Verified

July 1, 2023

Enrollment Period

5 months

First QC Date

June 5, 2023

Last Update Submit

July 15, 2023

Conditions

Keywords

laparoscopic pancreaticoduodenectomypancreatic 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 (3)

  • surgical performance of pancreaticojejunostomy

    intraoperatively

  • postoperative morbidity

    3 months postoperatively

  • postoperative mortality

    3 months postoperatively

Study Arms (2)

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

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.

Interventions

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

extended pancreatic transection cohort

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who had underwent laparoscopic pancreaticoduodenectomy

You may qualify if:

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

You may not qualify if:

  • conversion to laparotomy due to various reasons during operation;
  • combined with resection and reconstruction of the portal vein or the superior mesenteric vein
  • combined with other organ resection
  • 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
  • patients with the history of neoadjuvant chemotherapy or radiotherapy
  • the main pancreatic duct did not be found during the operation, the duct-to-mucosa pancreaticojejunostomy could not be performed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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: 32841726BACKGROUND
  • 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: 28990000BACKGROUND
  • 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: 12081065BACKGROUND

Study Officials

  • Bing Peng

    West China Hospital

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
attending doctor

Study Record Dates

First Submitted

June 5, 2023

First Posted

June 15, 2023

Study Start

August 1, 2023

Primary Completion

December 30, 2023

Study Completion

June 30, 2024

Last Updated

July 18, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share