Complication of Pancreatic Fistula and Bleeding After Pancreaticoduodenectomy in Treatment Periampullary Cancer

Bleeding Clinical Trial

— PF  

Official title:

Study of Pancreatic Fistula and Bleeding Complication After Pancreaticoduodenectomy in Treatment Periampullary Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04985071
• Other study ID #: VTrQuoc
• Status: Completed
• Start date: August 1, 2021
• Est. completion date: October 31, 2023

Study information

• Verified date: May 2024
• Source: University of Medicine and Pharmacy at Ho Chi Minh City
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This multi-site study will be done across Hepatobiliary and Pancreatic Surgery Department at Cho Ray Hospital and University and Pharmacy Center. Patients who are diagnosed with periampullary cancer from August 2021 to August 2023 will be underwent pancreaticoduodenectomy. We will follow-up for their pancreatic fistula and bleeding complication and analysis some risk factors.

Description:

The investigator will conduct this study at both site at the same time: Cho Ray Hospital and University and Pharmacy Center. The investigator will directly consult the patient to participate in the study, collect the preoperative information, intraoperative protocol and postoperative data. The investigator will statically analysis the incident of the morbidity (mainly for pancreatic fistula and bleeding), and invest some risk factors relating to those complications.

Plan for conducting the study:

• The patient diagnosed with periampullary cancer will be consulted with surgical method, operative risks, postoperative complications and agree to participate in the study. The patient signes a consent form to participate in the study.

• Pancreaticoduodenectomy will be performed according to the uniformity protocol of both hospitals: Cho Ray Hospital and University of Medicine and Pharmacy Center.

• Post-operative data will be collected and based on the general procedure.

Data analysis

• To determine the incidence of pancreatic fistula and bleeding, survival analysis will be used.

• To determine the association of risk factors with pancreatic fistula and bleeding, logistic regression was used, the value with p < 0.05 will be included in the multivariable regression model to determine the real risk factors.

Sample size:

• The investigator expect approximately 100 patients in the first year in both centers. And the investigator hope at least 110 patients in the whole conducting time.

Plan for missing data:

• The investigator will directly collect the patient information before the operation, observe the operation process and follow-up the postoperative during. Investigator will remove any case that missing preoperative information, operative data or post-operative laboratory test.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients diagnosed with periampullary cancer meet the following criteria:

• Possibility to perform pancreaticoduodenectomy based on preoperative imaging and intraoperative exploration.

• The postoperative pathology is adenocarcinoma (of the ampulla of Vater, common bile duct, duodenum or pancreas)

Exclusion Criteria:

• The patient has other organ's cancer beyond periampullary cancer.

• Patient's medical conditions contraindicate for anesthesia.

• The patient does not consent to participate in the study

Related Conditions & MeSH terms

• Bleeding
• Fistula
• Hemorrhage
• Pancreatic Fistula
• Periampullary Cancer

Intervention

Procedure:
• Pancreaticoduodenectomy
Patient with periampullary cancer will be underwent pancreaticoduodenectomy in 2 types of pancreatic-jejunal anastomosis reconstructions. We describe the postoperative complications (pancreatic fistula and bleeding) and analysis the risk factors relate to those complications

Locations

Country	Name	City	State
Vietnam	Phan Minh Tri	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
Vo Truong Quoc

Country where clinical trial is conducted

Vietnam, 

References & Publications (1)

Melloul E, Lassen K, Roulin D, Grass F, Perinel J, Adham M, Wellge EB, Kunzler F, Besselink MG, Asbun H, Scott MJ, Dejong CHC, Vrochides D, Aloia T, Izbicki JR, Demartines N. Guidelines for Perioperative Care for Pancreatoduodenectomy: Enhanced Recovery A — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pancreatic fistula	Rate of post-operative pancreatic fistula, risk factors associate to pancreatic fistula	90 post-operative days
Secondary	Bleeding complication	Rate and location of post-operative bleeding, risk factors relate to this complication	90 post-operative days

External Links

•   Guidelines for Perioperative Care for Pancreaticoduodenectomy