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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Delayed Gastric Emptying

Intervention / Treatment
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* Procedure: Pancreatoduodenectomy with antrectomy
* Procedure: Pylorus-preserving pancreatoduodenectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Patients undergoing pancreatoduodenectomy with antrectomy | Procedure: Pancreatoduodenectomy with antrectomy<br> <br> |
| Experimental: Study group<br>Patients undergoing pancreatoduodenectomy with pylorus-preserving pancreatoduodenectomy | Procedure: Pylorus-preserving pancreatoduodenectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative morbidity | Appearance of any complication during the hospital stay | within the first 90 days after surgery | 
| Postoperative mortality | Any death that happens during the hospital admission or within 90 days after surgery | within the first 90 days after surgery | 
| Length of hospital stay | Postoperative hospital stay after pancreatoduodenectomy | within the first 90 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delayed Gastric Emptying, Pylorus-preserving pancreatoduodenectomy