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Completed

NCT Number: NCT00639314

Trial on the Evaluation of Pylorus-ring in Pancreaticoduodenectomy

The purpose of this study is to clarify whether resecting pylorus-ring decreases delayed gastric emptying after pancreaticoduodenectomy and improves postoperative quality of life (QOL).

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Key information

About this study

The purpose of this study is to clarify whether resecting pylorus-ring decreases delayed gastric emptying after pancreaticoduodenectomy and improves postoperative quality of life(QOL)compared with preserving pylorus-ring. Delayed gastric emptying after pancreaticoduodenectomy are important to affect the postoperative course and QOL. However, there is no report that demonstrates the postoperative course between resecting pylorus-ring and preserving pylorus-ring. We conducted a prospective randomized trial on 130 patients who underwent pancreaticoduodenectomy comparing resecting pylorus-ring and preserving pylorus-ring.

The primary endpoint was defined as the decrease of delayed gastric emptying. The secondary endpoints were QOL, mortality and morbidity, including pancreatic fistula, intra-abdominal hemorrhage, and intra-abdominal abscess. Patients were recruited into this study before surgery, on the basis of whether pancreatic head resection was anticipated at Wakayama Medical University Hospital(WMUH) for pancreatic head and periampullary disease, and appropriate informed consent was obtained. Exclusion criteria was 1) patients with severe complications which were possible to prolong hospital stay, 2) patients who were diagnosed inadequacy for this study by a physician, 3) patients with a previous gastric resection, and 4) patients without an informed consent.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • On the basis of whether pancreatic head resection was anticipated at WMUH for pancreatic head and periampullary disease, and appropriate informed consent was obtained.

Exclusion criteria

  • Patients with severe complications which were possible to prolong hospital stay
  • Patients who were diagnosed inadequacy for this study by a physician
  • Patients who could not be placed a pancreatic stent tube
  • Patients without an informed consent.

Treatment and study plan

pylorus-preserving pancreaticoduodenectomy

Procedure

pylorus-preserving resection is division of the duodenum 3-4cm distal to the pylorus

pylorus-resecting pancreaticoduodenectomy

Procedure

In PrPD, the stomach is divided just above the pylorus ring. The nearly total stomach more than 95% was preserved.

Primary outcomes

  1. delayed gastric empty after pancreaticoduodenectomy

    Time frame: 1 month

Secondary outcomes

  1. evaluation of quality of life, early and late complications after pancreaticoduodenectomy

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Wakayama Medical University

Other

Registry information

Official study title

Randomized Controlled Trial on the Evaluation of Pylorus-ring in Pancreaticoduodenectomy

Important dates

Study start
2005
Primary completion
2009
Study completion
2011
First posted
Mar 20, 2008
Registry last updated
Jun 27, 2011

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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