Open Versus Laparoscopic Pancreaticoduodenectomy: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Overall Morbidity (Clavien-Dindo Classification)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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-
- •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 .
Arms & Interventions
Open Pancreaticoduodenectomy (OPD)
Patients randomized to receive standard open pancreaticoduodenectomy through a bilateral subcostal incision.
Intervention: Open Pancreaticoduodenectomy (Procedure)
Laparoscopic Pancreaticoduodenectomy (LPD)
Patients randomized to receive total laparoscopic pancreaticoduodenectomy using a standardized six-port technique.
Intervention: Laparoscopic Pancreaticoduodenectomy (Procedure)
Outcomes
Primary Outcomes
Overall Morbidity (Clavien-Dindo Classification)
Time Frame: 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 Outcomes
- Length of Hospital Stay(Up to 90 days.)
- Number of Lymph Nodes Retrieved(14 days postoperative.)
- Resection Margin Status (R0/R1/R2)(14 days postoperative.)
- Operative Time(Intraoperative)
- Estimated Blood Loss(Intraoperative)
Investigators
Saleh Khairy Saleh MD
Lecturer
Minia University