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Quality of Life and Nutritional Status After Two Surgical Techniques in Pancreatoduodenectomy

Randomized Trial Comparing Quality of Life and Nutritional Status Between Pylorus-preserving Pancreatoduodenectomy Versus Standard Pancreatoduodenectomy (QUANUPAD TRIAL)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03984734
Acronym
QUANUPAD
Enrollment
80
Registered
2019-06-13
Start date
2003-08-31
Completion date
2008-08-31
Last updated
2019-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delayed Gastric Emptying

Keywords

Delayed Gastric Emptying, Pylorus-preserving pancreatoduodenectomy

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.

Interventions

PROCEDUREPancreatoduodenectomy with antrectomy
PROCEDUREPylorus-preserving pancreatoduodenectomy

Sponsors

Hospital Universitari de Bellvitge
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence and severity of DGEwithin the first 90 days after surgeryNasogastric tube not removed before the 10th postoperative days or if liquids were not tolerated before the 14th postoperative day

Secondary

MeasureTime frameDescription
Postoperative morbiditywithin the first 90 days after surgeryAppearance of any complication during the hospital stay
Postoperative mortalitywithin the first 90 days after surgeryAny death that happens during the hospital admission or within 90 days after surgery
Length of hospital staywithin the first 90 days after surgeryPostoperative hospital stay after pancreatoduodenectomy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026