Clinical trial NCT07022015: Predictive Risk Factors for Pancreatic Fistula After Pancreaticoduodenectomy
Official title: Predictive Risk Factors for Postoperative Pancreatic Fistula After Pancreaticoduodenectomy for Malignancy.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pancreas Cancer
Pancreas Neoplasm
Pancreatic Fistula
Pancreas Adenocarcinoma
Periampullary Cancer
Periampullary Carcinoma
Resectable Pancreatic Cancer
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2025-06-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pancreaticoduodenectomy (PD) is a complex procedure performed in patients with malignant or benign tumors of the pancreatic head and periampullary region, associated with high morbidity and mortality. Postoperative pancreatic fistula (POPF) is the most common and clinically significant complication following PD. In this study, the investigators aim to determine the predictive risk factors for clinically related postoperative pancreatic fistula (CR-POPF) in the preoperative, intraoperative and postoperative period in patients that underwent PD. The total number of 100 participants expected to be included in this research who underwent PD between 2025 and 2026.

Detailed description: Pancreaticoduodenectomy (PD) is a complex procedure performed in patients with malignant or benign tumors of the pancreatic head and periampullary region, associated with high morbidity and mortality rates. Despite dramatic advancements in surgical techniques and perioperative management, reported morbidity and mortality rates following PD are 41.56% and 2.88%, respectively, which remain unsatisfactory. Postoperative pancreatic fistula (POPF) is the most common and clinically significant complication following PD. Therefore, accurate and timely prediction of POPF after PD is necessary to reduce secondary mortality from serious complications and optimize individual patient treatment decisions. This study aimed to determine the predictive risk factors for clinically related postoperative pancreatic fistula (CR-POPF) in the preoperative, intraoperative and postoperative period in patients that underwent PD.

Eligibility criteria: Inclusion Criteria:

* Patients with resectable distal common bile duct carcinoma, periampullary carcinoma, duodenal carcinoma, and carcinoma of the head of the pancreas.
* Patients meeting the curative treatment intent in accordance with clinical guidelines:

  * No evidence of metastasis.
  * Radiological non-involvement of superior mesenteric vein \& portal vein.
* American Society of Anesthesiologists (ASA) scores I \& II.
* Patients aged \> 18 years.
* Ability to understand and the willingness to sign a written informed consent document
* Agreement to complete the study

Exclusion Criteria:

* Unfit patients for surgery due to severe medical illness.
* Inoperable patients with distant metastases, including peritoneal, liver, distant lymph node metastases, and involvement of other organs.
* Irresectable tumors in diagnostic laparoscopy.
* History of other malignant disease.
* Pregnant or breast-feeding women.
* Patients with serious mental disorders.
* Patients with vascular invasion and requiring vascular resection as evaluated by the multidisciplinary team according to abdominal imaging data.
* Pancreatoduodenectomy for other diagnosis like cystic lesions, benign tumors or chronic calcific pancreatitis
* Patients refused to participate in the study.

Primary outcomes:
measure: Incidence of clinically relevant post operative pancreatic fistula
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Liver and GIT hospital , Minia University
Study officials:
affiliation: Minia University
name: Saleh K Saleh, MD
role: PRINCIPAL_INVESTIGATOR
References: