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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

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.

Condition or disease Intervention/treatment Phase
Delayed Gastric Emptying Procedure: Pancreatoduodenectomy with antrectomy Procedure: Pylorus-preserving pancreatoduodenectomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing Quality of Life and Nutritional Status Between Pylorus-preserving Pancreatoduodenectomy Versus Standard Pancreatoduodenectomy (QUANUPAD TRIAL)
Actual Study Start Date : August 2003
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control group
Patients undergoing pancreatoduodenectomy with antrectomy
Procedure: Pancreatoduodenectomy with antrectomy
Experimental: Study group
Patients undergoing pancreatoduodenectomy with pylorus-preserving pancreatoduodenectomy
Procedure: Pylorus-preserving pancreatoduodenectomy



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Postoperative morbidity [ Time Frame: within the first 90 days after surgery ]
    Appearance of any complication during the hospital stay

  2. 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

  3. Length of hospital stay [ Time Frame: within the first 90 days after surgery ]
    Postoperative hospital stay after pancreatoduodenectomy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984734


Sponsors and Collaborators
Hospital Universitari de Bellvitge
Investigators
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Principal Investigator: Juan Fabregat Prous, Dr. Hospital Universitari de Bellvitge

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Responsible Party: BUSQUETS, JULI, Staff surgeon Bellvitge Universitary Hospital, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT03984734     History of Changes
Other Study ID Numbers: QUANUPAD
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by BUSQUETS, JULI, Hospital Universitari de Bellvitge:
Delayed Gastric Emptying
Pylorus-preserving pancreatoduodenectomy

Additional relevant MeSH terms:
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Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms