Evaluation of the efficacy and safety of Hemopatch vs Fibrin sealant or patch vs no treatment on pancreatic fistula who underwent PPPD or distal pancreatectomy

Evaluation of the efficacy and safety of Hemopatch vs Fibrin sealant or patch vs no treatment on pancreatic fistula who underwent PPPD or distal pancreatectomy to treat benign or malignant pancreatic cancer: A single center, open-label, prospective, non-randomized, retrospective comparators, investigator-initiated pilot study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0006332

Enrollment

Registered

2021-07-09

Start date

2021-07-01

Completion date

Unknown

Last updated

2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : study subject 1) Control group 1: 25 patients with pancreatectomy without any application (medical record from 2008 to 2010) 2) Control group 2: 25 patients with tacosyl or neovil lab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Patients planning to undergo pylor-preserving pancreaticoduodenectomy or distal regional pancreatectomy due to benign or malignant pancreatic tumor - Patients with an ASA grade 1-2 score when selecting study subjects - Patients who consented and signed the informed consent form

Exclusion criteria

Exclusion criteria: - Patients who do not sign informed consent - Patients who are expected to reconstruct the arteries around the surgical site - Patients who received chemotherapy or radiation therapy before surgery - immunosuppressed patients

Design outcomes

Primary

Measure	Time frame
CRS-PF (Clinical Risk Score to Predict Pancreatic Fistula) : Pancreas Gland texture (Soft 1 , Firm 0) , Pathology (PDAC 1, Benign neoplasm 2, pancreatitis 3 ),pancreatic duct diameter (mm), estimated blood loss during surgery (mL) POPF (Postoperative pancreatic fistula)( biochemical leak: 0, grade B: 1, grade C: 2): serum amylase (U/L) 3 days post-surgery, humoral amylase (U/L) 3 days post-surgery, complications within 1 month after surgery : Bleeding, abscess, delayed gastric emptying, readmission within 1 month, reoperation within 1 month, percutaneous/endoscopic intervention within 1 month after surgery, surgery-related death within 3 months	—

Measure

Time frame

CRS-PF (Clinical Risk Score to Predict Pancreatic Fistula) : Pancreas Gland texture (Soft 1 , Firm 0) , Pathology (PDAC 1, Benign neoplasm 2, pancreatitis 3 ),pancreatic duct diameter (mm), estimated blood loss during surgery (mL) POPF (Postoperative pancreatic fistula)( biochemical leak: 0, grade B: 1, grade C: 2): serum amylase (U/L) 3 days post-surgery, humoral amylase (U/L) 3 days post-surgery, complications within 1 month after surgery : Bleeding, abscess, delayed gastric emptying, readmission within 1 month, reoperation within 1 month, percutaneous/endoscopic intervention within 1 month after surgery, surgery-related death within 3 months

—

Secondary

Measure	Time frame
Gender, age, type of bile drainage before surgery, ASA grade 1.2.3, body mass index, name of operation (pylorus-preserving pancreaticoduodenectomy 1, Whipple operation 2, distal pancreatectomy 3), operation time (min)	—

Countries

Korea, Republic of

Contacts

Public ContactKwang Yeol Paik

The Catholic University of Korea, Yeouido St. Mary's Hospital

godking121@naver.com+82-2-3779-1175

Outcome results