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NCT Number: NCT05657366

Peritoneal Lavage on the Incidence of Pancreatic Fistula and Related Complications After Pancreatoduodenectomy

As one of the possible strategies to prevent pancreatic fistula, peritoneal lavage is still widely used in clinical practice, but it lacks more evidence of evidence-based medicine and recommendations of guidelines. Some clinicians believe that routine flushing after pancreatoduodenectomy wastes medical resources and has a negative impact on patients' comfort.

In this study, the investigators designed a multicenter prospective controlled trial to compare the effects of peritoneal lavage and natural drainage on the incidence of pancreatic fistula and related complications after pancreatoduodenectomy. To study the indications of peritoneal lavage.

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Key information

Conditions

Pancreatic Fistula Digestive System Diseases Digestive System Fistula Fistula Pancreatic Diseases Pancreaticoduodenal; Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The second affiliated hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Preoperative diagnosis was pancreatic head, lower common bile duct, ampulla and duodenum tumors;
  • Patients with resectable tumors evaluated by imaging examination, and patients who plan to undergo pancreatoduodenectomy;
  • Subjects informed consent, understood and were willing to cooperate with the trial protocol, and signed relevant documents.

Exclusion criteria

  • Complicated with severe liver, kidney, heart, brain, lung and other organ complications;
  • Intraoperative changes in surgical methods, such as patients with tumor dissemination and only abdominal opening and closing; Or it needs to be resected in combination with other organs;
  • Patients and their families do not understand the treatment implementation plan of this study;
  • Failure to complete follow-up;

Treatment and study plan

Peritoneal lavage

Procedure

Continuous abdominal flushing with normal saline

Primary outcomes

  1. Post-operative Pancreatic Fistula (POPF)

    Time frame: 30 days post-operative

    Presence of Amylase > 3 times the upper limit of normal in surgical drains

Secondary outcomes

  1. Biliary fistula

    Time frame: 90 days post-operative

    Output of bile from drains on or by POD 3, pancreaticojejunostomy leak should be ruled out

  2. Post-Pancreatectomy Hemorrhage

    Time frame: 90 days post-operative

    As defined by the International Study Group for Pancreatic Surgery (ISGPS), grade A, B and C rates

  3. Mortality

    Time frame: 90 days post-operative

    Death related to surgical morbidity

  4. Delayed Gastric Emptying

    Time frame: 90 days post-operative

    As defined by ISGPS, grade A, B and C rates

  5. Abdominal abscess or infection

    Time frame: 90 days post-operative

    Collection >5cm in size, containing gas bubbles, determining systemic signs of infection

  6. Gastrojejunal/Duodenojejunal fistula

    Time frame: 90 days post-operative

    Fistula from gastro/duodenojejunostomy

  7. Wound infection

    Time frame: 90 days post-operative

    Superficial and Deep Surgical Site Incisional Infection

  8. Length of Hospital Stay

    Time frame: 1 year post-operative

    calculated from the day of surgery to the day of discharge, adding up the days after a possible re-admission

  9. Reoperation

    Time frame: 90 days post-operative

    Need for new surgery due to severe morbidity

  10. Readmission

    Time frame: 30 days post-operative

    New admission within 30-days of discharge from hospital

  11. drainage tube duration

    Time frame: 90 days post-operative

    Retention time of abdominal drainage tube

Study contacts

Contact information is provided by the study sponsor or research team.

Huanbing Zhu, PhD

CONTACT

[email protected]

15857174159

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

The Effect of Peritoneal Lavage on the Incidence of Pancreatic Fistula and Related Complications After Pancreatoduodenectomy in Patients With Different Pancreatic Fistula Risk Scores

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Dec 20, 2022
Registry last updated
Apr 21, 2023

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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