Clinical trial NCT05569343: Risk Factors for Achieving TO After LDPPHR-t
Official title: Risk Factors for Achieving Textbook Outcome After Laparoscopic Duodenum-preserving Total Pancreatic Head Resection: a Retrospective, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Neoplasm of Uncertain Behavior Head
Keywords: Textbook outcome
Risk factors
Endoscopic nasobiliary drainage
Total pancreatic head resection
Duodenum-preserving
Laparoscopic
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: postoperative complications
timeFrame: up to 90 days
Secondary outcomes:
measure: Operation time
timeFrame: Intraoperative
measure: Intraoperative blood loss
timeFrame: Intraoperative
measure: Readmission
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Department of Biliary-Pancreatic Surgery, Affiliated Tongji Hospital
name: Renyi Qin, MD
role: STUDY_DIRECTOR
References: