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

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ClinicalTrials.gov Identifier: NCT03984734
Recruitment Status : Completed
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
BUSQUETS, JULI, Hospital Universitari de Bellvitge

Tracking Information
First Submitted Date  ICMJE March 25, 2019
First Posted Date  ICMJE June 13, 2019
Last Update Posted Date June 13, 2019
Actual Study Start Date  ICMJE August 2003
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
Incidence and severity of DGE [ Time Frame: within the first 90 days after surgery ]
Nasogastric tube not removed before the 10th postoperative days or if liquids were not tolerated before the 14th postoperative day
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • Postoperative morbidity [ Time Frame: within the first 90 days after surgery ]
    Appearance of any complication during the hospital stay
  • Postoperative mortality [ Time Frame: within the first 90 days after surgery ]
    Any death that happens during the hospital admission or within 90 days after surgery
  • Length of hospital stay [ Time Frame: within the first 90 days after surgery ]
    Postoperative hospital stay after pancreatoduodenectomy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Quality of Life and Nutritional Status After Two Surgical Techniques in Pancreatoduodenectomy
Official Title  ICMJE Randomized Trial Comparing Quality of Life and Nutritional Status Between Pylorus-preserving Pancreatoduodenectomy Versus Standard Pancreatoduodenectomy (QUANUPAD TRIAL)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Delayed Gastric Emptying
Intervention  ICMJE
  • Procedure: Pancreatoduodenectomy with antrectomy
  • Procedure: Pylorus-preserving pancreatoduodenectomy
Study Arms  ICMJE
  • Active Comparator: Control group
    Patients undergoing pancreatoduodenectomy with antrectomy
    Intervention: Procedure: Pancreatoduodenectomy with antrectomy
  • Experimental: Study group
    Patients undergoing pancreatoduodenectomy with pylorus-preserving pancreatoduodenectomy
    Intervention: Procedure: Pylorus-preserving pancreatoduodenectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 11, 2019)
80
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03984734
Other Study ID Numbers  ICMJE QUANUPAD
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party BUSQUETS, JULI, Hospital Universitari de Bellvitge
Study Sponsor  ICMJE Hospital Universitari de Bellvitge
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Juan Fabregat Prous, Dr. Hospital Universitari de Bellvitge
PRS Account Hospital Universitari de Bellvitge
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP