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

Catalan Institute of Health

Status: Completed

Conditions: Delayed Gastric Emptying

Treatments: Procedure: Pancreatoduodenectomy with antrectomy; Procedure: Pylorus-preserving pancreatoduodenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03984734

QUANUPAD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Control group

Active Comparator group

Description:

Patients undergoing pancreatoduodenectomy with antrectomy

Treatment:

Procedure: Pancreatoduodenectomy with antrectomy

Study group

Experimental group

Description:

Patients undergoing pancreatoduodenectomy with pylorus-preserving pancreatoduodenectomy

Treatment:

Procedure: Pylorus-preserving pancreatoduodenectomy