Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07080697

A Study to Evaluate Splenectomy on Debridement for Acute Necrotizing Pancreatitis With Pancreatic Sinistral Portal Hypertension

This study is a prospective, single-center, randomized controlled trial focusing on patients with acute necrotizing pancreatitis (ANP) complicated by pancreatic sinistral portal hypertension (PSPH). The study aims to study the impact of total splenectomy on the debridement efficacy, perioperative recovery, and prognosis of patients with ANP complicated by PSPH.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location status: Recruiting

Location contact

Ting-Bo Liang

CONTACT

[email protected]

086-571-87236688

About this study

This study is a prospective, single-center, randomized controlled trial focusing on patients with acute necrotizing pancreatitis (ANP) complicated by pancreatic sinistral portal hypertension (PSPH). A total of 66 participants are planned to be enrolled. The study aims to compare the outcomes of two surgical approaches: open debridement combined with distal pancreatectomy and total splenectomy versus open debridementalone. The objective is to observe the impact of total splenectomy on the debridement efficacy, perioperative recovery, and prognosis of patients with ANP complicated by PSPH. The primary observational indicators include postoperative length of hospital stay, postoperative cost, postoperative life quality, and the alleviation of PSPH. Secondary observational indicators encompass the number of unplanned reoperations, postoperative infection control, postoperative irrigation volume, postoperative antibiotic consumption, and postoperative platelet count change. The study will be carried out in accordance with the protocol.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 18 and 75 years.
  • Acute necrotic pancreatitis complicated by pancreatic sinistral portal hypertension.
  • Patients undergoing open debridement for infected pancreatic necrosis

Exclusion criteria

  • Patients with pre-existing heart, lung, liver, kidney, or other organ failure prior to acute pancreatitis (AP).
  • Patients with pre-existing conditions such as cirrhosis that may lead to portal hypertension prior to AP.
  • Patients with pre-existing hematological diseases prior to AP.
  • Patients undergoing laparoscopic or nephroscopic debridement.

Treatment and study plan

splenectomy

Procedure

Open Debridement combined with distal pancreatectomy and total splenectomy

Control

Procedure

Open Debridement alone

Primary outcomes

  1. Length of hospital stay after debridement

    Time frame: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)

    The total length of hospital stay after debridement, including readmissions.

  2. Degree of pancreatic sinistral portal hypertension

    Time frame: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)

    The degree of pancreatic sinistral portal hypertension after intervention

Secondary outcomes

  1. Intensive Care Unit stay post Operation

    Time frame: Perioperative

  2. Pancreatic Fistula

    Time frame: Perioperative

    The rate of pancreatic fistula

  3. Number of Draining Tube when Discharged

    Time frame: Perioperative

  4. Time of all draining tubes removal

    Time frame: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)

  5. Cost post debridement in the first hospitalization

    Time frame: Perioperative

  6. Number of unplanned re-admissions

    Time frame: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)

  7. Number of unplanned operations

    Time frame: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)

  8. Number of percutaneous drainage after debridement

    Time frame: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)

  9. Antibiotic use after treatment

    Time frame: Perioperative

  10. Abdominal lavage

    Time frame: Perioperative

    Abdominal lavage volume after treatment

  11. Life quality one year after treatment

    Time frame: Within one year after the last subject was treated

    Life quality one year after treatment was judged by the Short-Form 36 Health Survey (SF-36), encompassing both physical and mental health across eight dimensions: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The minimum value is 0%, the maximum value is 100%, and a higher score means a better life quality.

Other outcomes

  1. Platelet number after debridement

    Time frame: Within one year after the last subject was treated

Study contacts

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

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

The Impact of Splenectomy on Debridement Efficacy, Perioperative Recovery, and Prognosis in Patients With Acute Necrotizing Pancreatitis Complicated by Pancreatic Sinistral Portal Hypertension

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jul 23, 2025
Registry last updated
Jul 23, 2025

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.

Published trials that share one or more normalized conditions with this study.