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
About this trial
This is an interventional treatment trial for Delayed Gastric Emptying focused on measuring Delayed Gastric Emptying, Pylorus-preserving pancreatoduodenectomy
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.
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
NCT ID
NCT03984734
First Posted
March 25, 2019
Last Updated
June 11, 2019
Sponsor
Hospital Universitari de Bellvitge
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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