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

Delayed Gastric Emptying Clinical Trial

— QUANUPAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03984734
• Other study ID #: QUANUPAD
• Status: Completed
• Phase: N/A
• Start date: August 2003
• Est. completion date: August 2008

Study information

• Verified date: June 2019
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delayed Gastric Emptying
• Gastroparesis

Intervention

Procedure:
• Pancreatoduodenectomy with antrectomy

• Pylorus-preserving pancreatoduodenectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of DGE	Nasogastric tube not removed before the 10th postoperative days or if liquids were not tolerated before the 14th postoperative day	within the first 90 days after surgery
Secondary	Postoperative morbidity	Appearance of any complication during the hospital stay	within the first 90 days after surgery
Secondary	Postoperative mortality	Any death that happens during the hospital admission or within 90 days after surgery	within the first 90 days after surgery
Secondary	Length of hospital stay	Postoperative hospital stay after pancreatoduodenectomy	within the first 90 days after surgery