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NCT Number: NCT05573399

Early Oral Feeding for Patients After Pancreaticoduodenectomy

This study intends to retrospectively analyze the patients who underwent pancreatoduodenectomy and compare the safety and feasibility between early enteral nutrition through nasojejunal tube and early oral feeding after pancreatoduodenectomy. This study is expected to revise the guidelines for early nutritional support after pancreaticoduodenectomy, reduce postoperative complications, and provide better guidance for clinical work.

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Key information

Conditions

Pancreatoduodenectomy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Changhai Hospital

Shanghai, Shanghai Municipality, China

About this study

Pancreaticoduodenectomy is the standard treatment for periampullary and pancreatic head carcinomas, with the high incidence of perioperative complications ranging from 40% to 60%. Malnutrition is a relevant predictor of post-operative morbidity and mortality after pancreatic surgery. Adequate nutrition is the key to reduce perioperative complications, including abdominal infection, poor healing of wounds, and even gastrointestinal anastomotic leak. The optimal nutritional support method after Pancreaticoduodenectomy is still uncertain, and the current nutritional support methods are diverse. The results of an international survey showed that there was very poor or no agreement on postoperative strategies for the management of nutrition after Pancreaticoduodenectomy. Therefore, the investigators designed this retrospective study to evaluate which was safer and more feasible between early oral feeding and nasojejunal early enteral nutrition after Pancreaticoduodenectomy, using the method of propensity score weighting.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who underwent pancreaticoduodenectomy by a certain surgeon in Changhai Hospital
  • Patients who were treated with nasojejunal enteral nutrition or oral enteral nutrition after operation.

Exclusion criteria

  • Patients who underwent pancreaticoduodenectomy by other surgeons during the same period;
  • Patients who received other nutritional support rather than nasojejunal tube enteral nutrition or oral enteral nutrition after operation.

Treatment and study plan

Primary outcomes

  1. Perioperative complications

    Time frame: From Operation date to three months after operation

    Complications defined by ISGPS in perioperative period

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

Clinical Efficacy Analysis on Early Oral Feeding Versus Nasojejunal Early Enteral Nutrition for Patients After Pancreaticoduodenectomy

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Oct 10, 2022
Registry last updated
Oct 18, 2022

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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