A Study on the Occurrence Time of Grade-B Pancreatic Fistula After Pancreatoduodenectomy

Postoperative Pancreatic Fistula Clinical Trial

Official title:

A Study on the Occurrence Time of Clinically Relevant Postoperative Pancreatic Fistula of Grade-B After Pancreatoduodenectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05667272
• Other study ID #: SYuhang
• Status: Recruiting
• Start date: February 1, 2023
• Est. completion date: May 31, 2023

Study information

• Verified date: March 2023
• Source: Changzhou Second People's Hospital affiliated with Nanjing Medical University
• Contact: chunfu zhu, PhD
• Phone: +8613961190702
• Email: zcfmlm[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To confirm the time point of CR-POPF of grade-B that patients with biochemical leak after PD or LPD turned into.

Description:

1. To confirm the time point of CR-POPF of grade-B that patients with biochemical leak after PD or LPD turned into. 2. Establishment of risk assessment model for Grade B fistula.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: May 31, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients underwent Pancreatoduodenectomy (PD) or Laparoscopic pancreatoduodenectomy (LPD) surgery.
• Surgery performed by the same surgical team.

Exclusion Criteria:

• PD or LPD combined with another organ resection.
• PD or LPD performed due to trauma.
• PD or LPD for emergency treatment, such as the rupture and bleeding of tumor.
• Palliative resection.
• Patients with severe organ dysfunction before surgery.
• Patients treated with preoperative neoadjuvant chemotherapy or other treatments (Radiotherapy, targeted immunotherapy, etc.).
• Patients with missing data for clinical or radiographic variables.

Related Conditions & MeSH terms

• Fistula
• Pancreatic Fistula
• Postoperative Pancreatic Fistula

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
China	Changzhou Second People's Hospital affiliated to Nanjing Medical University	Changzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Changzhou Second People's Hospital affiliated with Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications	Postoperative complications for each patient	up to postoperative 30 days