Risk Factors for Achieving TO After LDPPHR-t

NCT ID: NCT05569343

Last Updated: 2022-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-08

Study Completion Date

2022-04-16

Brief Summary

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

Detailed Description

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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.

Conditions

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Pancreatic Neoplasm of Uncertain Behavior Head

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Textbook outcome group

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

No intervention

Intervention Type OTHER

This is an observational study without any intervention

Non-Textbook outcome group

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

No intervention

Intervention Type OTHER

This is an observational study without any intervention

Interventions

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No intervention

This is an observational study without any intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Peritoneal seeding or metastasis to distant sites.
2. Incomplete clinical data.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Renyi Qin, MD

Role: STUDY_DIRECTOR

Department of Biliary-Pancreatic Surgery, Affiliated Tongji Hospital

Locations

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

Wuhan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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TJDBPS12

Identifier Type: -

Identifier Source: org_study_id

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