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CompletedNCT05569343Updated Oct 6, 2022

Risk Factors for Achieving TO After LDPPHR-t

An observational study in Pancreatic Neoplasm of Uncertain Behavior Head, sponsored by Tongji Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-10-06.

Sponsored by Tongji Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
31
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

Increasing numbers of benign or low-grade malignant neoplasms at the head of pancreas are being diagnosed due to computed tomography (CT), magnetic resonance imaging (MRI) and endoscopic ultrasonography (EUS). Laparoscopic duodenum-preserving total pancreatic head resection (LDPPHR-t) has been accepted as a valid alternative treatment for benign and low-grade malignant neoplasms at the head of the pancreas. The evaluation of quality of LDPPHR-t is important for surgeons to improve surgical quality. Currently, the evaluation of surgical quality mainly depends on some single outcome indicators, such as morbidity, mortality, readmission rate, or hospital stay. These single outcome indicators are difficult to accurately reflect the overall surgical quality and the composite outcome measures may be better than single outcome indicators. Textbook outcome (TO) is such a composite concept and is realized when all the requirements after operation are achieved according to the "all or none" principle. TO reflects the ideal surgical outcome and is a multidimensional measure for surgical quality assurance. However, the risk factors for achieving TO after LDPPHR-t is unknown and no relevant articles have been reported so far. The objective of study was to identify the risk factors for achieving TO after LDPPHR-t.

02

Conditions studied

  • Pancreatic Neoplasm of Uncertain Behavior Head

Keywords

  • Textbook outcome
  • Risk factors
  • Endoscopic nasobiliary drainage
  • Total pancreatic head resection
  • Duodenum-preserving
  • Laparoscopic
03

In context

Lead sponsor

Tongji Hospital is the lead sponsor of 384 studies on the registry; 208 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Peritoneal seeding or metastasis to distant sites.
  2. Incomplete clinical data.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
31 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherNo intervention

    This is an observational study without any intervention

06

What researchers measure

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.

    Time frame: up to 90 days

Secondary outcomes

  1. Operation time

    Operation time defined as the time from skin incision or trocar placement to complete skin closure

    Time frame: Intraoperative

  2. Intraoperative blood loss

    Intraoperative blood loss recorded by the anesthetist using a vacuum system

    Time frame: Intraoperative

  3. Readmission

    Readmission defined as any readmission within 30 days after discharge

    Time frame: up to 30 days

07

Study locations

1 site
  • Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei 430030, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05569343
Lead sponsor
Tongji Hospital
Responsible party
Renyi Qin (Professor in Surgery, Chief Physician, Director of Surgical Supervision Department, Deputy Director of Institute of Hepatobiliary&Pancreatic, Director of Department of Biliary-Pancreatic Surgery, Tongji Hospital) — Principal investigator
First posted
Oct 6, 2022
Start date
May 8, 2020
Primary completion
Dec 23, 2021
Completion
Apr 16, 2022
Last update
Oct 6, 2022

Study contacts

Renyi Qin, MD
study director · Department of Biliary-Pancreatic Surgery, Affiliated Tongji Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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