Open Versus Laparoscopic Assisted Pancreaticoduodenectomy
Primary Purpose
Pancreas Neoplasm
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laparoscopic assisted pancreaticoduodenectomy
Open pancreaticduodenctomy
Sponsored by
About this trial
This is an interventional treatment trial for Pancreas Neoplasm
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Laparoscopic assisted pancreaticoduodenctomy
Open pancreaticduodenctomy
Arm Description
If inclusion criteria are met ,these group of patients will undergo Laparoscopic assisted pancreaticoduodenctomy.
criteria are met ,these group of patients will undergo open pancreaticoduodenctomy
Outcomes
Primary Outcome Measures
post operative pain.
Compare the post operative pain betweenopen and laparoscopic assisted pancreaticoduodenectomy
Blood loss
Compare between the intra operative blood loss in the open and laparoscopic assisted pancreaticoduodenectomy
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
Secondary Outcome Measures
Postoperative haemorrhage
Compare between the postoperative haemorrhage by cc in the open and laparoscopic assisted pancreaticoduodenectomy
Postoperative wound infection.
Compare between the postoperative wound infection in the open and laparoscopic assisted pancreaticoduodenectomy
Starting oral feeding
Compare between starting oral feeding in the open and laparoscopic assisted pancreaticoduodenectomy
Postoperative 30 days mortality rate.
Compare between the Postoperative 30 days mortality rate in the open and laparoscopic assisted pancreaticoduodenectomy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05463328
Brief Title
Open Versus Laparoscopic Assisted Pancreaticoduodenectomy
Official Title
Open Versus Laparoscopic Assisted Pancreaticoduodenectomy: Randomized Control Comparative Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2022 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Neoplasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic assisted pancreaticoduodenctomy
Arm Type
Experimental
Arm Description
If inclusion criteria are met ,these group of patients will undergo Laparoscopic assisted pancreaticoduodenctomy.
Arm Title
Open pancreaticduodenctomy
Arm Type
Active Comparator
Arm Description
criteria are met ,these group of patients will undergo open pancreaticoduodenctomy
Intervention Type
Procedure
Intervention Name(s)
laparoscopic assisted pancreaticoduodenectomy
Intervention Description
laparoscopic assisted pancreaticoduodenectomy.
Intervention Type
Procedure
Intervention Name(s)
Open pancreaticduodenctomy
Intervention Description
Open pancreaticduodenctomy
Primary Outcome Measure Information:
Title
post operative pain.
Description
Compare the post operative pain betweenopen and laparoscopic assisted pancreaticoduodenectomy
Time Frame
Compare the post operative pain between open and laparoscopic assisted pancreaticoduodenctomy in the first week after operation
Title
Blood loss
Description
Compare between the intra operative blood loss in the open and laparoscopic assisted pancreaticoduodenectomy
Time Frame
Compare the intra operative blood loss between open and laparoscopic assisted pancreaticoduodenectomy during the operation
Title
Rate of postoperative anastomosis leakage(pancreatic,billary and intestinal).
Description
Compare the rate of postoperative anastomosis leakage(pancreatic,billary and intestinal) between the open and laparoscopic assisted pancreaticoduodenctomy
Time Frame
Rate of postoperative anastomosis leakage(pancreatic,billary and intestinal) in the first month after operation
Secondary Outcome Measure Information:
Title
Postoperative haemorrhage
Description
Compare between the postoperative haemorrhage by cc in the open and laparoscopic assisted pancreaticoduodenectomy
Time Frame
In the first 2 weeks
Title
Postoperative wound infection.
Description
Compare between the postoperative wound infection in the open and laparoscopic assisted pancreaticoduodenectomy
Time Frame
In the first 2 weeks
Title
Starting oral feeding
Description
Compare between starting oral feeding in the open and laparoscopic assisted pancreaticoduodenectomy
Time Frame
In the first 3 days after operation
Title
Postoperative 30 days mortality rate.
Description
Compare between the Postoperative 30 days mortality rate in the open and laparoscopic assisted pancreaticoduodenectomy
Time Frame
In the first 30days after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohammed aly ahmed, Assist.lecturer
Phone
01067575588
Email
mohamed1234ali1991@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mostafa Mahmoud Mohammed Sayed, Assist.prof
Phone
+201271207839
Email
mostafa.sayed@aun.edu.eg
12. IPD Sharing Statement
Citations:
PubMed Identifier
25801594
Citation
Newhook TE, LaPar DJ, Lindberg JM, Bauer TW, Adams RB, Zaydfudim VM. Morbidity and mortality of pancreaticoduodenectomy for benign and premalignant pancreatic neoplasms. J Gastrointest Surg. 2015 Jun;19(6):1072-7. doi: 10.1007/s11605-015-2799-y. Epub 2015 Mar 24.
Results Reference
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PubMed Identifier
34232515
Citation
Erratum to "Cancer statistics, 2021". CA Cancer J Clin. 2021 Jul;71(4):359. doi: 10.3322/caac.21669. Epub 2021 Apr 19. No abstract available.
Results Reference
background
PubMed Identifier
32061329
Citation
Correction to Lancet Gastroenterol Hepatol 2019; 4: 934-47. Lancet Gastroenterol Hepatol. 2020 Mar;5(3):e2. doi: 10.1016/S2468-1253(20)30018-2. No abstract available.
Results Reference
background
PubMed Identifier
30675490
Citation
Bausch D, Keck T. Minimally Invasive Surgery of Pancreatic Cancer: Feasibility and Rationale. Visc Med. 2018 Dec;34(6):440-443. doi: 10.1159/000495324. Epub 2018 Nov 28.
Results Reference
background
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Open Versus Laparoscopic Assisted Pancreaticoduodenectomy
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