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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreas Neoplasm

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

    First Posted
    April 8, 2022
    Last Updated
    July 18, 2022
    Sponsor
    Assiut University
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    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
    background
    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
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