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Completed

NCT Number: NCT03791450

Investigation of Pancreaticoduodenectomy

The investigators intend to conduct a multicentre, big-sample, retrospective study to analysis the surgery results of pancreaticoduodenectomy and compare the different suture technique.

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Key information

Conditions

Pancreaticoduodenectomy

Sex eligibility

All sexes

Study type

Observational

Primary location

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

About this study

For patients with malignant or benign disease of the pancreatic head and periampullary region, pancreaticoduodenectomy is the only potential approach to radical cure. However, pancreaticoduodenectomy is consider as one of the most complex operations associated with a high rate of postoperative complications such as pancreatic fistula, delayed gastric emptying, hemorrhage, abscess, and sepsis. These complications increase the costs associated with pancreaticoduodenectomy. Numerous interventions and techniques have been introduced to decrease the morbidity. But there is little evidence for the superiority of one anastomotic technique over the others. Therefore, investigators intend to conduct a multicentre, big-sample, retrospective study to analysis the surgery results of pancreaticoduodenectomy and compare the different suture technique.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients who had underwent pancreaticoduodenectomy between 2008 to 2018.

Exclusion criteria

None

Treatment and study plan

Primary outcomes

  1. Incidence of Postoperative Pancreatic Fistula(POPF)

    Time frame: Within 30 days after surgery

    The frequency of POPF occurs and the POPF will be strictly diagnosis and classified according to IGSPF criteria.

Secondary outcomes

  1. Morbidity

    Time frame: Within 90 days after surgery

    The incidence of operative complications within 90 days after surgery

  2. Mortality

    Time frame: Within 30 days after surgery

    The death occurred within 30 days after surgery

  3. Duration of operation

    Time frame: Intraoperative

    The time of operation count by minute.

  4. Length of hospital stay after surgery

    Time frame: From first day after surgery to release from hospital (anticipate 5 days minimally)

    Days between surgery and hospital discharge

  5. Hospital costs

    Time frame: From first day after surgery to release from hospital (anticipate 5 days minimally)

    The total hospitalization expenses

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

A Multicenter Big⁃Sample Retrospective Study of Pancreaticoduodenectomy

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 2, 2019
Registry last updated
Mar 4, 2020

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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