Clinical trial NCT03984734: Quality of Life and Nutritional Status After Two Surgical Techniques in Pancreatoduodenectomy
Official title: Randomized Trial Comparing Quality of Life and Nutritional Status Between Pylorus-preserving Pancreatoduodenectomy Versus Standard Pancreatoduodenectomy (QUANUPAD TRIAL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delayed Gastric Emptying
Keywords: Delayed Gastric Emptying
Pylorus-preserving pancreatoduodenectomy
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2019-06-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence and severity of DGE
timeFrame: within the first 90 days after surgery
Secondary outcomes:
measure: Postoperative morbidity
timeFrame: within the first 90 days after surgery
measure: Postoperative mortality
timeFrame: within the first 90 days after surgery
measure: Length of hospital stay
timeFrame: within the first 90 days after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Universitari de Bellvitge
name: Juan Fabregat Prous, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.