Invasive Intervention of Local Complications of Acute Pancreatitis
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT06023771 |
Recruitment Status :
Recruiting
First Posted : September 5, 2023
Last Update Posted : September 5, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Acute Pancreatitis | Procedure: Invasive intervention for acute pancreatitis |
Study Type : | Observational |
Estimated Enrollment : | 100 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Drainage and Debridement of Local Complications of Acute Pancreatitis: A Single-center Real-world Prospective Study |
Estimated Study Start Date : | October 2023 |
Estimated Primary Completion Date : | October 2026 |
Estimated Study Completion Date : | December 2026 |
Group/Cohort | Intervention/treatment |
---|---|
Acute pancreatitis requiring invasive intervention
Single-center cohort of acute pancreatitis patients requiring invasive intervention for the treatment of local complications during the whole course of disease.
|
Procedure: Invasive intervention for acute pancreatitis
Invasive interventions include drainage (endoscopic transmural drainage, imaging-guided percutaneous catheter drainage) and debridement (endoscopic debridement, videoscopic assisted retroperitoneal debridement, laparoscopic surgical debridement, open surgical debridement). |
- Major complications or death [ Time Frame: Day 1 from admission until 6 months after discharge ]A composite of major complications (i.e., new-onset multiple organ failure or systemic complications, enterocutaneous fistula or perforation of a visceral organ requiring intervention, or intraabdominal bleeding requiring intervention) or death during admission or during the 6 months after discharge.
- Organ failure [ Time Frame: Day 1 from admission until 6 months after discharge ]New-onset ( not present at any time in the 24 hours before first intervention) pulmonary failure, circulatory failure, or renal failure
- Systemic complication [ Time Frame: Day 1 from admission until 6 months after discharge ]New-onset ( not present at any time in the 24 hours before first intervention) systematic complications such as disseminated intravascular coagulation, severe metabolic disturbance, and gastrointestinal bleeding
- Enterocutaneous fistula [ Time Frame: Day 1 from admission until 6 months after discharge ]Secretion of fecal material from a percutaneous drain or drainage canal after removal of drains or from a surgical wound, either from small or large bowel; confirmed by imaging or during surgery
- Perforation of visceral organ [ Time Frame: Day 1 from admission until 6 months after discharge ]Perforation requiring surgical, radiologic, or endoscopic intervention
- Intraabdominal bleeding [ Time Frame: Day 1 from admission until 6 months after discharge ]Requiring surgical, radiologic, or endoscopic intervention
- Pancreatic fistula [ Time Frame: Day 1 from admission until 6 months after discharge ]Output, through a percutaneous drain or drainage canal after removal of drains or from a surgical wound, of any measurable volume of fluid with an amylase content >3 times the serum amylase level
- New-onset diabetes [ Time Frame: Day 1 from admission until 6 months after discharge ]Insulin or oral antidiabetic drugs required 6 mo after discharge; this requirement was not present before onset of pancreatitis
- Use of pancreatic enzymes [ Time Frame: Day 1 from admission until 6 months after discharge ]Oral pancreatic-enzyme supplementation required to treat clinical symptoms of steatorrhea 6 mo after discharge; this requirement was not present before onset of pancreatitis
- Length of hospitalization [ Time Frame: Day 1 from admission until the 1 day of discharge ]Total days of hospitalization for the management of acute pancreatitis
- Length of intesive care [ Time Frame: Day 1 from admission until the 1 day of discharge ]Total days in intesive care unit for the management of acute pancreatitis
- Total direct medical costs and indirect costs [ Time Frame: Day 1 from admission until the 1 day of discharge ]Total direct medical costs and indirect costs during admission
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Admission diagnosis of acute pancreatitis;
- Localized complications confirmed by imaging examinations;
- Voluntary participation in the study and signing of an informed consent form.
Exclusion Criteria:
- Improved with conservative treatment without invasive interventions for local complications during hospitalization.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06023771
Contact: Dong Wu | 18612671010 | wudong@pumch.cn |
China, Beijing | |
Peking Union Medical College Hospital | Recruiting |
Beijing, Beijing, China, 100730 | |
Contact: Dong Wu |
Principal Investigator: | Dong Wu | Peking Union Medical College Hospital |
Responsible Party: | Peking Union Medical College Hospital |
ClinicalTrials.gov Identifier: | NCT06023771 |
Other Study ID Numbers: |
K4433 |
First Posted: | September 5, 2023 Key Record Dates |
Last Update Posted: | September 5, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pancreatitis Pancreatic Diseases Digestive System Diseases |