Outcomes After Laparoscopic Versus Open Pancreaticoduodenectomy

Minia University90 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Ductal Adenocarcinoma

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 .

Outcomes

Primary Outcomes

Overall Morbidity (Clavien-Dindo Classification)

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.

Time frame: 90 days postoperative.

Secondary Outcomes

Number of Lymph Nodes Retrieved

Total count of lymph nodes harvested and examined by pathology.

Time frame: 14 days postoperative.

Resection Margin Status (R0/R1/R2)

Pathological assessment of margins (Pancreatic neck, bile duct, retroperitoneal, etc.) classified as R0 (\>1mm), R1 (≤1mm), or R2 (macroscopic).

Time frame: 14 days postoperative.

Operative Time

Time measured from skin incision to skin closure.

Time frame: Intraoperative

Estimated Blood Loss

Total blood loss recorded by the anesthesiology team.

Time frame: Intraoperative

Length of Hospital Stay

Total number of days from admission to discharge.

Time frame: Up to 90 days.