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CompletedNCT05616403Updated Nov 15, 2022

Textbook Outcome as a Composite Outcome Measure in Laparoscopic Pancreaticoduodenectomy

An observational study in Pancreatic Neoplasms, sponsored by Tongji Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-11-15.

Sponsored by Tongji Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,029
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This is a multicenter, retrospective, observational study. Textbook outcome is a composite outcome measure for surgical quality assessment. The aim of this study was to assess textbook outcome following laparoscopic pancreaticoduodenectomy in China, identify factors independently associated with achieving textbook outcome and analyze hospital variations regarding the textbook outcome after case-mix adjustment.

Read the detailed description

Laparoscopic pancreaticoduodenectomy (LPD) remains one of the most complex and technically challenging procedures in pancreatic surgery, although LPD has developed rapidly worldwide in recent years. Traditionally, quality assessment of LPD has mainly focused on individual outcome measures such as morbidity, mortality, operative time, operative blood transfusion, readmission rates and length of hospital stay. However, individual outcome parameters do not reflect the multiple facets of the whole surgical procedure and do not measure actual variations among different hospitals. In this context, several outcome experts have suggested that composite measures of surgical quality may be better than individual outcome parameters to compare hospital performance. Textbook outcome (TO) is such a composite outcome measure of multiple desirable outcome metrics, which was first proposed in 2013 by Dutch colorectal surgeons in order to give a comprehensive summary of hospital performance. TO is realized when all of the desired outcome parameters are achieved following surgery and represents the optimal ("textbook") hospitalization.

Although several studies on TO in pancreatic surgery have been reported, relevant data on LPD are lacking, especially from China. The objective of this study was to assess TO among patients undergoing LPD in China, identify factors independently associated with achieving TO and analyze hospital variations regarding the TO after case-mix adjustment.

02

Conditions studied

  • Pancreatic Neoplasms

Keywords

  • textbook outcome
  • laparoscopic pancreaticoduodenectomy
  • composite outcome measure
  • hospital variation
03

In context

Pancreatic Neoplasms

3,310 studies on the registry are indexed under Pancreatic Neoplasms; 910 are open to participants now.

This study's enrollment of 1,029 is above the median of 200 across 636 observational studies indexed under Pancreatic Neoplasms.

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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.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients underwent laparoscopic pancreaticoduodenectomy from 16 high-volume pancreatic centers in China from January 2010 and August 2016.

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 pancreaticoduodenectomy.
  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
1,029 participants (actual)
Patient registry
No

Groups and cohorts

  • Textbook outcome group

    Achieving textbook outcome after laparoscopic pancreaticoduodenectomy

    Other: No intervention

  • Non-Textbook outcome group

    Not achieving textbook outcome after laparoscopic pancreaticoduodenectomy

    Other: No intervention

Interventions

  • OtherNo intervention

    This is an observational study without any intervention

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What researchers measure

Primary outcomes

  1. Textbook outcome

    Textbook outcome was defined as the absence of postoperative pancreatic fistula, postpancreatectomy hemorrhage, bile leakage, severe complications (Clavien-Dindo grade ≥ Ⅲ), in-hospital or 30-day mortality, and readmission within 30 days after discharge.

    Time frame: up to 90 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

References and documents

Publications

  • Wu Y, Peng B, Liu J, Yin X, Tan Z, Liu R, Hong D, Zhao W, Wu H, Chen R, Li D, Huang H, Miao Y, Liu Y, Liang T, Wang W, Yuan J, Li S, Zhang H, Wang M, Qin R; Minimally Invasive Treatment Group in the Pancreatic DiseaseBranch of China's International Exchange and Promotion Association for Medicine and Healthcare (MITG-P-CPAM). Textbook outcome as a composite outcome measure in laparoscopic pancreaticoduodenectomy: a multicenter retrospective cohort study. Int J Surg. 2023 Mar 1;109(3):374-382. doi: 10.1097/JS9.0000000000000303. PubMed 36912568 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05616403
Lead sponsor
Tongji Hospital
Collaborators
West China Hospital, The Second Hospital of Hebei Medical University, Hunan Provincial People's Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Chinese PLA General Hospital, Sir Run Run Shaw Hospital, The Affiliated Hospital of Xuzhou Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, First Affiliated Hospital of Chongqing Medical University, Fujian Medical University Union Hospital, The First Affiliated Hospital with Nanjing Medical University, Nanjing Medical University, The First Hospital of Jilin University, Zhejiang University, Huadong 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
Nov 15, 2022
Start date
Jan 18, 2010
Primary completion
Aug 28, 2016
Completion
Jan 15, 2021
Last update
Nov 15, 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 ↗

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

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