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

Not Applicable

Completed

• Conditions: Delayed Gastric Emptying
• Interventions: Procedure: Pancreatoduodenectomy with antrectomy; Procedure: Pylorus-preserving pancreatoduodenectomy

• Registration Number: NCT03984734
• Lead Sponsor: Hospital Universitari de Bellvitge

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 Timeline

• Study Start: 2003-08
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Study First Submitted: 2019-03-25
• Status Verified: 2019-06
• Study First Submitted QC: 2019-06-11
• Last Update Submitted: 2019-06-11
• Study First Posted: 2019-06-13
• Last Update Posted: 2019-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Pancreatoduodenectomy with antrectomy	Patients undergoing pancreatoduodenectomy with antrectomy
Study group	Pylorus-preserving pancreatoduodenectomy	Patients undergoing pancreatoduodenectomy with pylorus-preserving pancreatoduodenectomy

Primary Outcome Measures

Name	Time	Method
Incidence and severity of DGE	within the first 90 days after surgery	Nasogastric tube not removed before the 10th postoperative days or if liquids were not tolerated before the 14th postoperative day

Secondary Outcome Measures

Name	Time	Method
Postoperative mortality	within the first 90 days after surgery	Any death that happens during the hospital admission or within 90 days after surgery
Length of hospital stay	within the first 90 days after surgery	Postoperative hospital stay after pancreatoduodenectomy
Postoperative morbidity	within the first 90 days after surgery	Appearance of any complication during the hospital stay