NCT05569343

Brief Summary

This is a single, retrospective, observational study to investigate the risk factors for achieving textbook outcome after laparoscopic duodenum-preserving total pancreatic head resection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
Last Updated

October 6, 2022

Status Verified

October 1, 2022

Enrollment Period

1.6 years

First QC Date

October 3, 2022

Last Update Submit

October 4, 2022

Conditions

Pancreatic Neoplasm of Uncertain Behavior Head

Keywords

Textbook outcomeRisk factorsEndoscopic nasobiliary drainageTotal pancreatic head resectionDuodenum-preservingLaparoscopic

Outcome Measures

Primary Outcomes (1)

  • postoperative complications

    The postoperative complications were graded into mild complications and severe complications according to the Clavien-Dindo classification of surgical complications, including postpancreatectomy hemorrhage, postoperative pancreatic fistula , and bile leakage.

    up to 90 days

Secondary Outcomes (3)

  • Operation time

    Intraoperative

  • Intraoperative blood loss

    Intraoperative

  • Readmission

    up to 30 days

Study Arms (2)

Textbook outcome group

Achieving textbook outcome after laparoscopic duodenum-preserving total pancreatic head resection

Other: No intervention

Non-Textbook outcome group

Not achieving textbook outcome after laparoscopic duodenum-preserving total pancreatic head resection

Other: No intervention

Interventions

No interventionOTHER

This is an observational study without any intervention

Non-Textbook outcome groupTextbook outcome group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients underwent laparoscopic duodenum-preserving total pancreatic head resection in the department of Biliary-Pancreatic Surgery of Tongji Hospital from May 2020 to December 2021.

You may qualify if:

  • Patients underwent laparoscopic duodenum-preserving total pancreatic head resection.
  • Aged 18 to 75 years old.

You may not qualify if:

  • Peritoneal seeding or metastasis to distant sites.
  • Incomplete clinical data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Study Officials

  • Renyi Qin, MD

    Department of Biliary-Pancreatic Surgery, Affiliated Tongji Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Surgery, Chief Physician, Director of Surgical Supervision Department, Deputy Director of Institute of Hepatobiliary&Pancreatic, Director of Department of Biliary-Pancreatic Surgery

Study Record Dates

First Submitted

October 3, 2022

First Posted

October 6, 2022

Study Start

May 8, 2020

Primary Completion

December 23, 2021

Study Completion

April 16, 2022

Last Updated

October 6, 2022

Record last verified: 2022-10

Locations

CN(1)