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NCT Number: NCT06241586

A Novel Surgical Strategy to Reduce Major Complications in Patients With Necrotizing Pancreatitis

The goal of this observational study is to compare patient outcomes between the groups of patients admitted before and after the full implementation of the novel surgical strategy in patients with necrotizing pancreatitis. The main question it aims to answer are:

• the efficacy and safety of the novel surgical strategy To assess the efficacy and safety of the novel surgical strategy, all included patients were divided into two groups according to the timing of receiving treatment: 1) the early period group: patients admitted before January 2021 received the hybrid strategy of traditional and novel surgical strategies; and 2) the late period group: patients admitted during and after January 2021 received the complete novel surgical strategy.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tianjin NanKai Hospital

Tianjin, None Selected, China

Who can participate

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

Inclusion criteria

Consecutive patients older than 18 years with necrotizing pancreatitis were included.

Exclusion criteria

Patients who met one or more of the following criteria were excluded: (1) had a past medical history of acute pancreatitis; (2) had drainage or surgery for pancreatic necrosis in other hospitals before admission to our institute; and (3) did not complete the treatment strategy owing to nonmedical reasons.

Treatment and study plan

The novel PMMI surgical strategy

Procedure

Immediate drainagewas advocated within 24 hours once necrosis was diagnosed. During the treatment course, a hybrid approach was available by flexibly switching interventions. Open surgery was only applied when patients required emergency surgery.

The minimally invasive surgery was selected based on the size, location, and maturity of the necrotic area and stepwise response to intervention. Repeated peritoneal purification was performed until the infected or devitalized tissue was controlled. Patients were subsequently discharged with a drainage catheter and readmitted at 7- to 10-day intervals to receive repeated planned surgery without postoperative irrigation. Patients received a whole-course assessment for individual patients at 7-day predetermined intervals.

The conventional step-up strategy

Procedure

Interventions were postponed until 4 weeks after the onset of pancreatitis in line with international guidelines unless the patient showed evidence of progressive clinical deterioration despite the use of maximal supportive care. Patients underwent CT-guided percutaneous catheter drainage as the first step. Treatment response was evaluated after 3 days. If drainage was clinically unsuccessful, a VARD procedure was performed. Similarly, open surgery, which was described by Beger et al., was performed if the VARD procedure failed. Postoperative continuous lavage is performed as a routine procedure.

Primary outcomes

  1. major complications

    Time frame: 90-day follow up

Secondary outcomes

  1. mortality

    Time frame: 90-day follow up

  2. Admission of ICU

    Time frame: up to 90-days

  3. Length of hospital stay

    Time frame: up to 90-days

  4. individual major complications

    Time frame: 90-day follow up

    The overall complications included procedure-related complications (intra-abdominal and gastrointestinal bleeding, pancreatic fistulas, and gastrointestinal perforation) and nonspecific complications (systemic inflammatory response syndrome, abdominal compartment syndrome, and new-onset renal, respiratory and circulatory failure).

Sponsors and collaborators

Lead sponsor

Tianjin Nankai Hospital

Other

Registry information

Official study title

A Novel Surgical Strategy to Reduce Major Complications in Patients With Necrotizing Pancreatitis: A Retrospective Cohort Study

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Feb 5, 2024
Registry last updated
Feb 5, 2024

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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