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Efficacy and safety comparison of endoscopic ultrasound-guided lauromacrogol ablation versus saline lavage followed by paclitaxel and gemcitabine injection for the treatment of pancreatic cystic neoplasms: A multicenter, non-inferiority, single-blind, randomized controlled trial (ESLPN protocol)

Efficacy and safety comparison of endoscopic ultrasound-guided lauromacrogol ablation versus saline lavage followed by paclitaxel and gemcitabine injection for the treatment of pancreatic cystic neoplasms: A multicenter, non-inferiority, single-blind, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600129506
Enrollment
Unknown
Registered
2026-08-05
Start date
2026-08-15
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pancreatic cystic neoplasms

Interventions

Experimental group: EUS guided lauromacrogol ablation
control group: EUS?guided saline lavage combined with paclitaxel and gemcitabine ablation

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Imaging diagnosis of mucinous cystic neoplasm (MCN) or PCN with associated symptoms (jaundice, pancreatitis, abdominal pain, etc. caused by compression of the common bile duct, main pancreatic duct, or gastrointestinal tract), or PCN whose nature cannot be determined by imaging; 2. Aged 18–85 years.

Exclusion criteria

Exclusion criteria: 1. Patients who were readmitted during the study period to undergo EUS ablation; 2. Patients with >=6 cysts; 3. Patients with a pancreatic cystic neoplasm (PCN) communicating with the main pancreatic duct; 4. Patients in whom the possibility of malignancy cannot be ruled out (presence of wall nodules, solid components, eggshell-like calcifications in the wall, cytology of cyst fluid suggestive of malignancy or high-grade dysplasia, main pancreatic duct dilation >10 mm, or symptoms caused by the condition); 5. Acute pancreatitis or signs of pancreatic necrosis; pancreatic pseudocysts; 6. Contraindications to EUS; contraindications to anesthesia; contraindications to paclitaxel, poliglavonol, or gemcitabine; 7. Other conditions deemed by the investigator to render the patient unsuitable for enrollment, or a short life expectancy; 8. Pregnant or breastfeeding women; 9. Patients with coagulation disorders; 10. Patients who are unwilling or unable to provide informed consent.

Design outcomes

Primary

MeasureTime frame
resolved rate;

Secondary

MeasureTime frame
complication rate;complete resolved rate;partial resolved rate;Diabetes mellitus rate;pancreatic cancer rate;Incidence of symptoms such as abdominal pain and jaundice;Length of Hospital Stay and Costs;

Countries

China

Contacts

Public ContactChai Ningli

Chinese PLA General Hospital

530713082@qq.com+86 10 6693 7485

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026