Open Versus Laparoscopic Assisted Pancreaticoduodenectomy

Not Applicable

• Conditions: Pancreas Neoplasm
• Interventions: Procedure: Open pancreaticduodenctomy; Procedure: laparoscopic assisted pancreaticoduodenectomy

• Registration Number: NCT05463328
• Lead Sponsor: Assiut University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-04-08
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-18
• Last Update Submitted: 2022-07-18
• Study First Posted: 2022-07-19
• Last Update Posted: 2022-07-19
• Study Start: 2022-12-01
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. age less than 70 years.
2. resectable tumour,
3. fit for surgery

Exclusion Criteria

1. patients with jaundice with serum bilirubin above 200mml/dl.
2. patients with bleeding tendency until corrected.
3. patients with advanced and metastatic malignancy.
4. patients with cardiopulmonary diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open pancreaticduodenctomy	Open pancreaticduodenctomy	criteria are met ,these group of patients will undergo open pancreaticoduodenctomy
Laparoscopic assisted pancreaticoduodenctomy	laparoscopic assisted pancreaticoduodenectomy	If inclusion criteria are met ,these group of patients will undergo Laparoscopic assisted pancreaticoduodenctomy.

Primary Outcome Measures

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

Secondary Outcome Measures

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