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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Pancreaticoduodenectomy (OPD) | Active Comparator | Patients randomized to receive standard open pancreaticoduodenectomy through a bilateral subcostal incision. |
|
| Laparoscopic Pancreaticoduodenectomy (LPD) | Experimental | Patients randomized to receive total laparoscopic pancreaticoduodenectomy using a standardized six-port technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open Pancreaticoduodenectomy | Procedure | Open Pancreaticoduodenectomy with lymphadenectomy and reconstruction via open technique. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 days postoperative. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Lymph Nodes Retrieved | Total count of lymph nodes harvested and examined by pathology. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Saleh K Saleh, MD | Contact | 01201765401 | +2 | salehkhairy@mu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Saleh K Saleh, MD | Minia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liver and GIT hospital , Minia University | Recruiting | Minya | Minya Governorate | 61519 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26158612 | Result | Adam MA, Choudhury K, Dinan MA, Reed SD, Scheri RP, Blazer DG 3rd, Roman SA, Sosa JA. Minimally Invasive Versus Open Pancreaticoduodenectomy for Cancer: Practice Patterns and Short-term Outcomes Among 7061 Patients. Ann Surg. 2015 Aug;262(2):372-7. doi: 10.1097/SLA.0000000000001055. | |
| 30138162 | Result | Poves I, Burdio F, Morato O, Iglesias M, Radosevic A, Ilzarbe L, Visa L, Grande L. Comparison of Perioperative Outcomes Between Laparoscopic and Open Approach for Pancreatoduodenectomy: The PADULAP Randomized Controlled Trial. Ann Surg. 2018 Nov;268(5):731-739. doi: 10.1097/SLA.0000000000002893. |
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| ID | Term |
|---|---|
| D007516 | Adenoma, Islet Cell |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Laparoscopic Pancreaticoduodenectomy | Procedure | Minimally invasive Whipple procedure using 6 trocars, with specimen extraction via Pfannenstiel incision. |
|
| 14 days postoperative. |
| Operative Time | Time measured from skin incision to skin closure. | Intraoperative |
| Estimated Blood Loss | Total blood loss recorded by the anesthesiology team. | Intraoperative |
| Length of Hospital Stay | Total number of days from admission to discharge. | Up to 90 days. |
| D010190 |
| Pancreatic Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |