Optimal Timing of Endoscopic Intervention in the Treatment of Chronic Pancreatitis.
TEST
1 other identifier
interventional
220
1 country
1
Brief Summary
This study aims to determine the optimal timing of endoscopic intervention after extracorporeal shock wave lithotripsy(ESWL) of chronic pancreatitis with pancreatic stones.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2022
CompletedFirst Posted
Study publicly available on registry
March 8, 2022
CompletedStudy Start
First participant enrolled
March 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2025
CompletedNovember 19, 2025
November 1, 2025
7 months
January 10, 2022
November 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Successful MPD Cannulation Rates
technical success rate of pancreatic cannulation
during ERCP procedure
Secondary Outcomes (3)
Successful clearance of MPD stones
during ERCP procedure
post-ERCP complications
30 days
severity of post-ERCP complications
30 days
Other Outcomes (2)
Treatment-related costs in RMB from initial enrollment to the end of the study
through endotherapy completion, an average of 14days
The hospitalization time
through endotherapy completion, an average of 14days
Study Arms (2)
Endoscopic group <12h
EXPERIMENTALThe patients received intravenous analgesia (flurbiprofen and remifentanil) before the ESWL (Compact Delta II; Dornier Med Tech, Wessling, Germany). After the last ESWL session, the patients are treated with following ERCP within 12h. ERCP was performed under conscious sedation with intramuscular administration of diazepam 2.5-5.0 mg and pethidine 25-50 mg. If necessary, endoscopic sphincterotomy was performed. A dilating bougie or balloon will be used to dilate the stenosis after sphincterotomy. Standard techniques (i.e., extraction basket, extraction balloon, or both) will be used for stone removal. A pancreatic duct stent for drainage and nasopancreatic catheters will be inserted for temporary drainage if necessary.
Endoscopic group ≥12 h
ACTIVE COMPARATORThe patients received intravenous analgesia (flurbiprofen and remifentanil) before the ESWL (Compact Delta II; Dornier Med Tech, Wessling, Germany). The time scale between the last ESWL session and following ERCP is greater than 12h. ERCP was performed under conscious sedation with intramuscular administration of diazepam 2.5-5.0 mg and pethidine 25-50 mg. If necessary, endoscopic sphincterotomy was performed. A dilating bougie or balloon will be used to dilate the stenosis after sphincterotomy. Standard techniques (i.e., extraction basket, extraction balloon, or both) will be used for stone removal. A pancreatic duct stent for drainage and nasopancreatic catheters will be inserted for temporary drainage if necessary.
Interventions
The patients received intravenous analgesia before the ESWL. After the last ESWL session, the patients are treated with following ERCP within 12h.
The patients received intravenous analgesia before the ESWL. After the last ESWL session, the patients are treated with following ERCP ≥12 h.
Analgesics administrated include morphine, buprenorphine, pethidine, tramaldol, metamizole and acetylsalicylacid. They will only be administrated as needed.
Eligibility Criteria
You may qualify if:
- symptomatic adult patients diagnosed with chronic pancreatitis and main pancreatic duct positive stones（\>5mm in diameter）
- no ERCP and ESWL history before the admission
- provides informed consent
You may not qualify if:
- suspected to have malignant tumors;
- history of pancreatic surgery or gastrojejunostomy (Billroth II);
- with end-stage disease;
- with contraindications to ESWL or ERCP, such as pregnancy, abdominal aortic aneurysm, etc.
- acute pancreatitis within 3 days
- pancreatic ascites
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Changhai Hospital
Shanghai, 200433, China
Related Publications (1)
Guo JY, Qian YY, Sun H, Chen H, Zou WB, Hu LH, Li ZS, Xin L, Liao Z. Optimal Timing of Endoscopic Intervention After Extracorporeal Shock-Wave Lithotripsy in the Treatment of Chronic Calcified Pancreatitis. Pancreas. 2021 Apr 1;50(4):633-638. doi: 10.1097/MPA.0000000000001810.
PMID: 33939679BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhuan Liao, MD
Changhai Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
January 10, 2022
First Posted
March 8, 2022
Study Start
March 12, 2025
Primary Completion
October 18, 2025
Study Completion
October 20, 2025
Last Updated
November 19, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share