Analysis of Intraoperative Bleeding Characteristics in Laparoscopic Pancreaticoduodenectomy

• Sponsor: Xinrui Zhu，MD (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06128603
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Anticipated Duration (Months): 4.8
• Patients Per Site Per Month: 82.8

Study Details

Study Description

Brief Summary

In this study, we analyze the common bleeding characteristics in laparoscopic pancreaticoduodenectomy by reviewing and annotating bleeding information from previous surgical videos as well as surgical operation OSATS technique scores. From there, we reflect on the correlation between surgical operating technique and intraoperative bleeding, as well as on the correlation between intraoperative bleeding and short-term postoperative outcomes.

Condition or Disease	Intervention/Treatment	Phase
Laparoscopic Pancreaticoduodenectomy	Procedure: laparoscopic pancreaticoduodenectomy

Study Design

• Study Type: Observational
• Anticipated Enrollment: 400 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Analysis of Intraoperative Bleeding Characteristics in Laparoscopic Pancreaticoduodenectomy
• Actual Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Feb 25, 2024

Arms and Interventions

Arm	Intervention/Treatment
LPD group Cases who had underwent laparoscopic pancreaticoduodenectomy	Procedure: laparoscopic pancreaticoduodenectomy; laparoscopic pancreaticoduodenectomy was performed for periampullary benign and malignant diseases. Besides, the surgical video was recorded.

Outcome Measures

Primary Outcome Measures

1. intraoperative bleeding characteristics [intraoperatively]

   Bleeding characteristics include cause of bleeding, site of bleeding, size of bleeding, method of hemostasis, duration of hemostasis, and outcome of hemostasis. These would be obtained by reviewing and labeling laparoscopic pancreaticoduodenectomy surgical videos.

Secondary Outcome Measures

1. OSATS scores [intraoperatively]

   Scoring laparoscopic pancreaticoduodenectomy operations using the OSATS Surgical Operative Technique Rating Scale

2. textbook outcome [3 months postoperatively]

   The textbook outcome was defined as the absence of all six individual outcomes: clinically relevant postoperative pancreatic fistula, post-pancreatectomy hemorrhage, bile leak, severe complications (Clavien-Dindo≥3), readmission, and mortality within 30 days postoperatively

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• the surgical video is complete including the resection and reconstruction phases

Exclusion Criteria:

• the surgical video is not complete

• the cases combined with resection and reconstruction of mesentericoportal vein

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West China Hospital of Sichuan University	Chengdu	Sichuan	China	610041

Sponsors and Collaborators

• Xinrui Zhu，MD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xinrui Zhu，MD, attending doctor, West China Hospital
• ClinicalTrials.gov Identifier: NCT06128603
• Other Study ID Numbers: 2023-1663-1
• First Posted: Nov 13, 2023
• Last Update Posted: Nov 13, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Xinrui Zhu，MD, attending doctor, West China Hospital: laparoscopic pancreaticoduodenectomy; intraoperative bleeding; OSATS scores; short-time outcomes
• Additional relevant MeSH terms: Hemorrhage; Blood Loss, Surgical

Study Results

No Results Posted as of Nov 13, 2023