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NCT Number: NCT03984734

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pancreatoduodenectomy with antrectomy

Procedure

Pylorus-preserving pancreatoduodenectomy

Procedure

Primary outcomes

  1. Incidence and severity of DGE

    Time frame: 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 outcomes

  1. Postoperative morbidity

    Time frame: within the first 90 days after surgery

    Appearance of any complication during the hospital stay

  2. Postoperative mortality

    Time frame: within the first 90 days after surgery

    Any death that happens during the hospital admission or within 90 days after surgery

  3. Length of hospital stay

    Time frame: within the first 90 days after surgery

    Postoperative hospital stay after pancreatoduodenectomy

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Registry information

Official study title

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

Acronym: QUANUPAD

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Jun 13, 2019
Registry last updated
Jun 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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