Using a pancreatic stent before surgery to prevent complications after distal pancreatectomy
Preoperative Endoscopic Pancreatic Stent to Prevent Pancreatic Fistula After Distal Pancreatectomy: a Randomized Controlled Trial
NA · Chinese University of Hong Kong · NCT05297136
This study is testing if placing a stent in the pancreas before surgery can help prevent complications after a specific type of pancreatic surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong (other) |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT05297136 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of preoperative pancreatic duct stenting in preventing postoperative pancreatic fistula (POPF) following distal pancreatectomy, with or without splenectomy. Patients will be randomly assigned to receive either a pancreatic stent placed 1-2 weeks before surgery or to undergo surgery without the stent. The study will compare the rates of POPF, morbidity, mortality, and total length of hospital stay between the two groups. The stent will be removed four weeks after the operation, allowing for a thorough assessment of its impact on recovery.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are scheduled for elective distal pancreatectomy due to primary pancreatic conditions.
Not a fit: Patients who may not benefit include those requiring emergency distal pancreatectomy or those with conditions that complicate the procedure, such as pancreatic duct stricture or altered anatomy.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of postoperative pancreatic fistula, improving recovery outcomes for patients undergoing distal pancreatectomy.
How similar studies have performed: While the use of pancreatic stenting is a recognized technique, this specific approach in a randomized controlled trial setting is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18 years * Elective distal pancreatectomy for primary pancreatic pathology Exclusion Criteria: * Informed consent not available * Emergency distal pancreatectomy * Presence of pancreatic duct stricture * Presence of altered anatomy that precludes safe Endoscopic Retrograde Cholangiography (e.g. previous Billroth II gastrectomy) * History of severe pancreatitis
Where this trial is running
Hong Kong
- Prince of Wales Hospital — Hong Kong, Hong Kong (RECRUITING)
Study contacts
- Principal investigator: Kit Fai Lee, MBBS — Clinical Associate Professor (honorary)
- Study coordinator: Kit Fai Lee, MBBS
- Email: leekf@surgery.cuhk.edu.hk
- Phone: 35051496
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pancreatectomy, Pancreatic Fistula, Distal Pancreatectomy