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Quality of Life and Nutritional Status After Two Surgical Techniques in Pancreatoduodenectomy (QUANUPAD)

Primary Purpose

Delayed Gastric Emptying

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pancreatoduodenectomy with antrectomy
Pylorus-preserving pancreatoduodenectomy
Sponsored by
Hospital Universitari de Bellvitge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delayed Gastric Emptying focused on measuring Delayed Gastric Emptying, Pylorus-preserving pancreatoduodenectomy

Eligibility Criteria

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

Inclusion Criteria:

  • Patients who underwent surgical resection of the head of the pancreas at the authors' institution from August 2003 to August 2008. Adults of either sex aged over 18 years were included.

Exclusion Criteria:

  • Associated resections of other organs, except for the portal or superior mesenteric vein
  • Total pancreatectomy
  • Previous gastrectomy or other gastric surgeries
  • Neoadjuvant treatment
  • Liver cirrhosis.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Control group

    Study group

    Arm Description

    Patients undergoing pancreatoduodenectomy with antrectomy

    Patients undergoing pancreatoduodenectomy with pylorus-preserving pancreatoduodenectomy

    Outcomes

    Primary Outcome Measures

    Incidence and severity of DGE
    Nasogastric tube not removed before the 10th postoperative days or if liquids were not tolerated before the 14th postoperative day

    Secondary Outcome Measures

    Postoperative morbidity
    Appearance of any complication during the hospital stay
    Postoperative mortality
    Any death that happens during the hospital admission or within 90 days after surgery
    Length of hospital stay
    Postoperative hospital stay after pancreatoduodenectomy

    Full Information

    First Posted
    March 25, 2019
    Last Updated
    June 11, 2019
    Sponsor
    Hospital Universitari de Bellvitge
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03984734
    Brief Title
    Quality of Life and Nutritional Status After Two Surgical Techniques in Pancreatoduodenectomy
    Acronym
    QUANUPAD
    Official Title
    Randomized Trial Comparing Quality of Life and Nutritional Status Between Pylorus-preserving Pancreatoduodenectomy Versus Standard Pancreatoduodenectomy (QUANUPAD TRIAL)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2003 (Actual)
    Primary Completion Date
    August 2008 (Actual)
    Study Completion Date
    August 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Universitari de Bellvitge

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This was a randomized unblinded single-centre trial. The main hypothesis of the study was that pylorus-preserving pancreatoduodenectomy reduces the incidence of delayed gastric emptying . Patients undergoing pancreatoduodenectomy were randomized to undergo one of two types of surgical technique: pylorus-preserving pancreatoduodenectomy versus stardard pancreatoduodenectomy with antrectomy. The primary endpoint was the incidence and severity of delayed gastric emptying. Secondary endpoints were postoperative morbidity and mortality, length of hospital stay, and nutritional status and quality of life.
    Detailed Description
    This was a randomized unblinded single-centre trial without masked evaluation of the main outcome.The authors decided to compare pancreatoduodenectomy with antrectomy versus pancreatoduodenectomy with pyloric preservation. The primary aim of this randomized clinical trial was to determine whether pancreatoduodenectomy with pyloric preservation is associated with a lower incidence and severity of delayed gastric emptying. Secondary endpoints were postoperative complications, postoperative mortality and duration of hospital stay. Patients undergoing pancreatoduodenectomy were randomized to undergo one of two types of gastroenteric anastomosis for reconstruction. Analytical parameters such as C-reactive protein, prealbumin, and albumin; as well as anthropometric measures (mean) as preoperative arm circumference mean and tricipital skinfold mean were registered preoperatively, at 5th week, and at 6th mounth. Scintigraphic study had performed following a specific protocol for gastric emptying. At the end, quality of life was also analized with a quality of life questionnaire (QLPAN26) preoperativelly and postoperatively.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Delayed Gastric Emptying
    Keywords
    Delayed Gastric Emptying, Pylorus-preserving pancreatoduodenectomy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Patients undergoing pancreatoduodenectomy with antrectomy
    Arm Title
    Study group
    Arm Type
    Experimental
    Arm Description
    Patients undergoing pancreatoduodenectomy with pylorus-preserving pancreatoduodenectomy
    Intervention Type
    Procedure
    Intervention Name(s)
    Pancreatoduodenectomy with antrectomy
    Intervention Type
    Procedure
    Intervention Name(s)
    Pylorus-preserving pancreatoduodenectomy
    Primary Outcome Measure Information:
    Title
    Incidence and severity of DGE
    Description
    Nasogastric tube not removed before the 10th postoperative days or if liquids were not tolerated before the 14th postoperative day
    Time Frame
    within the first 90 days after surgery
    Secondary Outcome Measure Information:
    Title
    Postoperative morbidity
    Description
    Appearance of any complication during the hospital stay
    Time Frame
    within the first 90 days after surgery
    Title
    Postoperative mortality
    Description
    Any death that happens during the hospital admission or within 90 days after surgery
    Time Frame
    within the first 90 days after surgery
    Title
    Length of hospital stay
    Description
    Postoperative hospital stay after pancreatoduodenectomy
    Time Frame
    within the first 90 days after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients who underwent surgical resection of the head of the pancreas at the authors' institution from August 2003 to August 2008. Adults of either sex aged over 18 years were included. Exclusion Criteria: Associated resections of other organs, except for the portal or superior mesenteric vein Total pancreatectomy Previous gastrectomy or other gastric surgeries Neoadjuvant treatment Liver cirrhosis.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Juan Fabregat Prous, Dr.
    Organizational Affiliation
    Hospital Universitari de Bellvitge
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35786739
    Citation
    Busquets J, Martin S, Secanella L, Sorribas M, Cornella N, Altet J, Pelaez N, Bajen M, Carnaval T, Videla S, Fabregat J. Delayed gastric emptying after classical Whipple or pylorus-preserving pancreatoduodenectomy: a randomized clinical trial (QUANUPAD). Langenbecks Arch Surg. 2022 Sep;407(6):2247-2258. doi: 10.1007/s00423-022-02583-9. Epub 2022 Jul 4.
    Results Reference
    derived

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    Quality of Life and Nutritional Status After Two Surgical Techniques in Pancreatoduodenectomy

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