Randomized Trial Comparing Quality of Life and Nutritional Status Between Pylorus-preserving Pancreatoduodenectomy Versus Standard Pancreatoduodenectomy (QUANUPAD TRIAL)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Delayed Gastric Emptying
- Sponsor
- Hospital Universitari de Bellvitge
- Enrollment
- 80
- Primary Endpoint
- Incidence and severity of DGE
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
BUSQUETS, JULI
Staff surgeon Bellvitge Universitary Hospital
Hospital Universitari de Bellvitge
Eligibility Criteria
Inclusion Criteria
- •Patients who underwent surgical resection of the head of the pancreas at the authors' institution from August 2003 to August
- •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.
Outcomes
Primary Outcomes
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 Outcomes
- Postoperative morbidity(within the first 90 days after surgery)
- Postoperative mortality(within the first 90 days after surgery)
- Length of hospital stay(within the first 90 days after surgery)