Study on Predictive Factors, Safety and Efficacy of Endoscopic Retrograde Accessory Pancreatography in CP

NCT06684301 | Completed DMC

• 1 other identifier: CHEC2022-238
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic pancreatitis (CP) can manifest characteristic pathological modifications such as pancreatic duct stenosis and pancreatic duct lithiasis. The endoscopic access to the main pancreatic duct through the major duodenal papilla is prevalently recognized as the most preponderant approach for endoscopic treatment of CP. Given that a multitude of CP patients are accompanied by main pancreatic duct stricture and distortion, certain patients encounter failure in main papilla angiography or are unable to achieve deep cannulation of the pancreatic duct, thus necessitating endoscopic retrograde accessory pancreatic ductography via the accessory papilla to augment the success rate of endoscopic drainage. Presently, there lacks a large - scale case report concerning the proportion of patients receiving main and accessory pancreatic ductography treatment and the safety and efficacy of endoscopic retrograde accessory pancreatic ductography in the treatment of CP. This study endeavors to establish a prospective cohort to document the proportion of CP patients undergoing main and accessory pancreatic duct angiography treatment and their clinical features during the initial endoscopic retrograde pancreatography (ERP). The main analysis centers on identifying the predictive factors for resorting to accessory pancreatic duct treatment subsequent to the failure of primary pancreatic duct angiography and assessing the safety and efficacy of endoscopic retrograde accessory pancreatic ductography in the treatment of CP.

Conditions

Chronic Pancreatitis

Keywords

Chronic Pancreatitis; Endoscopic Retrograde Pancreatography; Accessory Pancreatic Duct; Technical Success; Complication

Outcome Measures

Primary Outcomes (1)

• Success rate of accessory pancreatic ductography.

  The success rate of accessory pancreatic ductography is the percentage of successful imaging operations of the accessory pancreatic duct, crucial for assessing the efficacy of relevant procedures.

  during ERCP procedure

Secondary Outcomes (2)

• post-ERCP complications

  30 days after ERCP procedure

• clearance rates of pancreatic duct stones

  during ERCP procedure

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized in Changhai Hospital from 2022.09.15 to 2024.01.18.

You may qualify if:

• Patients with chronic pancreatitis hospitalized in Changhai Hospital from 2022.09.15 to 2024.01.18.
• Patients who completed endoscopic retrograde pancreatography.
• Aged 18 to 70 years,male or female.

You may not qualify if:

• Patients who accepted endoscopic retrograde pancreatography before.
• History of pancreatic surgery or Billroth II gastrectomy.
• Acute pancreatitis exacerbation or acute exacerbation of chronic pancreatitis
• Panceratic benign or malignant tumors.
• Pregnant or breastfeeding women.
• Patients who refused to participate in the study.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, 200433, China

Location

Related Publications (4)

• Tringali A, Voiosu T, Schepis T, Landi R, Perri V, Bove V, Voiosu AM, Costamagna G. Pancreas divisum and recurrent pancreatitis: long-term results of minor papilla sphincterotomy. Scand J Gastroenterol. 2019 Mar;54(3):359-364. doi: 10.1080/00365521.2019.1584640. Epub 2019 Mar 17.

  PMID: 30880501 BACKGROUND

• Brown NG, Howell DA, Brauer BC, Walker J, Wani S, Shah RJ. Minor papilla endotherapy in patients with ventral duct obstruction: identification and management. Gastrointest Endosc. 2017 Feb;85(2):365-370. doi: 10.1016/j.gie.2016.07.066. Epub 2016 Aug 13.

  PMID: 27530069 BACKGROUND

• Kwon CI, Gromski MA, Sherman S, El Hajj II, Easler JJ, Watkins J, McHenry L, Lehman GA, Fogel EL. Clinical response to dorsal duct drainage via the minor papilla in refractory obstructing chronic calcific pancreatitis. Endoscopy. 2017 Apr;49(4):371-377. doi: 10.1055/s-0042-120996. Epub 2017 Feb 15.

  PMID: 28201840 BACKGROUND

• Moffatt DC, Cote GA, Avula H, Watkins JL, McHenry L, Sherman S, Lehman GA, Fogel EL. Risk factors for ERCP-related complications in patients with pancreas divisum: a retrospective study. Gastrointest Endosc. 2011 May;73(5):963-70. doi: 10.1016/j.gie.2010.12.035. Epub 2011 Mar 9.

  PMID: 21392753 BACKGROUND

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Liang-hao Hu, MD

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2024
• First Posted: November 12, 2024
• Study Start: September 15, 2022
• Primary Completion: January 18, 2024
• Study Completion: February 18, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)