Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-27 @ 11:44 AM
Study NCT ID:
NCT03984734
Status:
COMPLETED
Last Update Posted:
2019-06-13
First Post:
2019-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life and Nutritional Status After Two Surgical Techniques in Pancreatoduodenectomy
Sponsor:
Hospital Universitari de Bellvitge
Organization:
Study Overview
Official Title:
Randomized Trial Comparing Quality of Life and Nutritional Status Between Pylorus-preserving Pancreatoduodenectomy Versus Standard Pancreatoduodenectomy (QUANUPAD TRIAL)
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QUANUPAD
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: