Ampullary Carcinoma, Distal Cholangiocarcinoma, Duodenal Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, Pancreatic Neuroendocrine Tumor
Conditions
Brief summary
This is a monocentric, prospective, randomized controlled trial comparing the safety and efficacy of laparoscopic pancreaticoduodenectomy (LPD) versus open pancreaticoduodenectomy (OPD). The study aims to determine the morbimortality of the laparoscopic approach compared to the gold standard open approach in adult patients with pancreatic or periampullary lesions.
Detailed description
This is a monocentric, prospective, randomized controlled trial comparing the safety and efficacy of laparoscopic pancreaticoduodenectomy (LPD) versus open pancreaticoduodenectomy (OPD). The study aims to determine the morbimortality of the laparoscopic approach compared to the gold standard open approach in adult patients with pancreatic or periampullary lesions. This study will randomize 90 eligible patients to receive either LPD or OPD. The primary objective is to compare overall morbidity using the Clavien-Dindo Classification at 90 days postoperative. Secondary objectives include assessment of oncologic outcomes (lymph node harvest, margin status), perioperative metrics (operative time, blood loss), and postoperative recovery (length of stay, readmissions). The study utilizes a prospectively maintained database and adheres to CONSORT guidelines.
Interventions
PROCEDUREOpen Pancreaticoduodenectomy
Open Pancreaticoduodenectomy with lymphadenectomy and reconstruction via open technique.
PROCEDURELaparoscopic Pancreaticoduodenectomy
Minimally invasive Whipple procedure using 6 trocars, with specimen extraction via Pfannenstiel incision.
Sponsors
Minia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years. * Histologically confirmed or clinically suspected lesions of: Pancreatic head adenocarcinoma, Ampullary carcinoma, Distal cholangiocarcinoma, Duodenal adenocarcinoma, Pancreatic neuroendocrine tumors, or Intraductal Papillary Mucinous Neoplasm(IPMN) . * Resectable disease based on preoperative imaging. * Eastern Cooperative Oncology Group(ECOG) performance status 0-2. * American Society of Anesthesiologists(ASA )classification I-III. * Patients able to provide informed consent.
Exclusion criteria
* Emergency surgery. * Previous pancreatic surgery. * Concurrent major abdominal procedures . * ASA classification IV or higher. * Metastatic disease identified preoperatively. * Locally advanced unresectable disease. * Active infection or sepsis at time of surgery. * Severe cardiopulmonary comorbidities precluding major surgery. * Pregnancy. * Procedures requiring Total Pancreatectomy, Distal Pancreatectomy, or Enucleation .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Morbidity (Clavien-Dindo Classification) | 90 days postoperative. | Assessment of all surgical complications graded by severity using the Clavien-Dindo Classification (Grades I-V). Major complications are defined as Grade III or higher. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Lymph Nodes Retrieved | 14 days postoperative. | Total count of lymph nodes harvested and examined by pathology. |
| Resection Margin Status (R0/R1/R2) | 14 days postoperative. | Pathological assessment of margins (Pancreatic neck, bile duct, retroperitoneal, etc.) classified as R0 (\>1mm), R1 (≤1mm), or R2 (macroscopic). |
| Operative Time | Intraoperative | Time measured from skin incision to skin closure. |
| Estimated Blood Loss | Intraoperative | Total blood loss recorded by the anesthesiology team. |
| Length of Hospital Stay | Up to 90 days. | Total number of days from admission to discharge. |
Countries
Egypt
Contacts
CONTACTSaleh K Saleh, MD
PRINCIPAL_INVESTIGATORSaleh K Saleh, MD
Minia University
Outcome results
None listed