Analysis of Intraoperative Bleeding Characteristics in Laparoscopic Pancreaticoduodenectomy

Laparoscopic Pancreaticoduodenectomy Clinical Trial

Official title:

Analysis of Intraoperative Bleeding Characteristics in Laparoscopic Pancreaticoduodenectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06128603
• Other study ID #: 2023-1663-1
• Status: Recruiting
• Start date: October 1, 2023
• Est. completion date: February 25, 2024

Study information

• Verified date: November 2023
• Source: West China Hospital
• Contact: He Cai, MD.
• Phone: +862862539242
• Email: 813021545[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: February 25, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage
• Laparoscopic Pancreaticoduodenectomy

Intervention

Procedure:
• laparoscopic pancreaticoduodenectomy
laparoscopic pancreaticoduodenectomy was performed for periampullary benign and malignant diseases. Besides, the surgical video was recorded.

Locations

Country	Name	City	State
China	West China Hospital of Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Xinrui Zhu,MD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraoperative bleeding characteristics	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.	intraoperatively
Secondary	OSATS scores	Scoring laparoscopic pancreaticoduodenectomy operations using the OSATS Surgical Operative Technique Rating Scale	intraoperatively
Secondary	textbook outcome	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	3 months postoperatively