Open Versus Laparoscopic Assisted Pancreaticoduodenectomy

Study Overview
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Brief Summary
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Compare open and laparoscopic assisted pancreaticoduodenectomy regarding intraoprative blood loss, organ injury, completion of planned laparoscopic steps, duration and early post operative course of pain, hem stability, oral feeding, leakage(pancreatic, billary and intestinal). ,bleeding, mortality, lymph nodes and safety margins .

Detailed Description
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Pancreaticoduodenectomy is the only option curative intended in the treatment of resectable pancreatic ductal adenocarcinomas, duodenal carcinoma, ampullary carcinoma, lower common bile duct cholangiocarcinoma,. It is still associated with very high morbidity and mortality. [1]. Pancreatic cancer ranks as the seventh leading cause of cancer-related death worldwide, and the fourth among other cancers[2,3]. In recent years, the minimally invasive techniques has considered revolution in surgeries of pancreatic cancers [4,5]. Laparoscopic assisted pancreaticoduodenectomy is a hybrid procedure combining laparoscopic resection and reconstruction through a small incision.it companies laparoscopic mobilization and dissection due to magnification compared with open pancreaticoduodenectomy[6]. Several studies have shown that laparoscopic assisted pancreaticoduodenectomy could result in less blood loss less, pain ,less wound infection and shorter hospital stay compared to open pancreaticoduodenectomy[7,8]. Limited literature described the safety and efficacy of laparoscopic assisted pancraticododenostomy .Also such comparative studies deficient in evaluation of outcomes of laparoscopic assisted pancraticododenostomy and open pancraticoduodenoctomy.So the interest of our study is to compare between the feasibility and safety of laparoscopic assisted pancraticododenostomy and open pancraticoduodenoctomy.

Official Title
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Open Versus Laparoscopic Assisted Pancreaticoduodenectomy: Randomized Control Comparative Prospective Study

Conditions
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Pancreas Neoplasm

Intervention / Treatment
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* Procedure: laparoscopic assisted pancreaticoduodenectomy
* Procedure: Open pancreaticduodenctomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age less than 70 years. resectable tumour, fit for surgery Exclusion Criteria: patients with jaundice with serum bilirubin above 200mml/dl. patients with bleeding tendency until corrected. patients with advanced and metastatic malignancy. patients with cardiopulmonary diseases.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic assisted pancreaticoduodenctomy<br>If inclusion criteria are met ,these group of patients will undergo Laparoscopic assisted pancreaticoduodenctomy. | Procedure: laparoscopic assisted pancreaticoduodenectomy<br>* laparoscopic assisted pancreaticoduodenectomy.<br>|
| Active Comparator: Open pancreaticduodenctomy<br>criteria are met ,these group of patients will undergo open pancreaticoduodenctomy | Procedure: Open pancreaticduodenctomy<br>* Open pancreaticduodenctomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post operative pain. | Compare the post operative pain betweenopen and laparoscopic assisted pancreaticoduodenectomy | Compare the post operative pain between open and laparoscopic assisted pancreaticoduodenctomy in the first week after operation | 
| Blood loss | Compare between the intra operative blood loss in the open and laparoscopic assisted pancreaticoduodenectomy | Compare the intra operative blood loss between open and laparoscopic assisted pancreaticoduodenectomy during the operation | 
| Rate of postoperative anastomosis leakage(pancreatic,billary and intestinal). | Compare the rate of postoperative anastomosis leakage(pancreatic,billary and intestinal) between the open and laparoscopic assisted pancreaticoduodenctomy | Rate of postoperative anastomosis leakage(pancreatic,billary and intestinal) in the first month after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative haemorrhage | Compare between the postoperative haemorrhage by cc in the open and laparoscopic assisted pancreaticoduodenectomy | In the first 2 weeks | 
| Postoperative wound infection. | Compare between the postoperative wound infection in the open and laparoscopic assisted pancreaticoduodenectomy | In the first 2 weeks | 
| Starting oral feeding | Compare between starting oral feeding in the open and laparoscopic assisted pancreaticoduodenectomy | In the first 3 days after operation | 
| Postoperative 30 days mortality rate. | Compare between the Postoperative 30 days mortality rate in the open and laparoscopic assisted pancreaticoduodenectomy | In the first 30days after operation |