RECRUITINGINTERVENTIONAL
Outcomes After Laparoscopic Versus Open Pancreaticoduodenectomy
Open Versus Laparoscopic Pancreaticoduodenectomy: A Randomized Controlled Trial
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Age ≥18 years.
- diagnosed by tissue sample (biopsy-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 willing to sign a consent form.
Who Should NOT Join This Trial:
- 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 .
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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 .
Treatments Being Tested
PROCEDURE
Open Pancreaticoduodenectomy
Open Pancreaticoduodenectomy with lymphadenectomy and reconstruction via open technique.
PROCEDURE
Laparoscopic Pancreaticoduodenectomy
Minimally invasive Whipple procedure using 6 trocars, with specimen extraction via Pfannenstiel incision.
Locations (1)
Liver and GIT hospital , Minia University
Minya, Minya Governorate, Egypt