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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05297136
Other study ID # 2021.728-T
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 21, 2022
Est. completion date May 20, 2026

Study information

Verified date March 2022
Source Chinese University of Hong Kong
Contact Kit Fai Lee, MBBS
Phone 35051496
Email leekf@surgery.cuhk.edu.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Distal pancreatectomy (DP) with or without splenectomy is commonly indicated for pancreatic body or tail lesions. Postoperative pancreatic fistula (POPF) remains the commonest complication after DP. A pre-operatively placed pancreatic stent across papilla can decrease the pressure gradient between pancreatic duct and duodenum. Therefore, the pancreatic juice flow is redirected from the pancreatic transection plane and leakage from pancreatic stump is much reduced. This study aims to evaluate whether pre-operatively placed pancreatic stent can prevent POPF by a randomized controlled trial.


Description:

A randomised-controlled trial is performed to evaluate the efficacy of preoperative pancreatic duct stenting in preventing post-operative pancreatic fistula after distal pancreatectomy with or without splenectomy. Patients will be randomised to pre-operative stent group or surgery alone group. Pre-operative pancreatic duct stenting will be performed 1-2 weeks before surgery. The stent will be removed 4 weeks after operation. The post-operative pancreatic fistula rate, morbidity, mortality and total length of stay were compared between the 2 groups.


Recruitment information / eligibility

Status Recruiting
Enrollment 56
Est. completion date May 20, 2026
Est. primary completion date March 20, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Pancreatic Stenting
Pancreatic stent of appropriate size and length is inserted to the pancreatic duct before distal pancreatectomy
No Stent
No preoperative stenting with distal pancreatectomy alone

Locations

Country Name City State
Hong Kong Prince of Wales Hospital Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with postoperative pancreatic fistula The number of participants developing post-operative pancreatic fistula, which is defined as drain fluid amylase more than 3 times the upper limit of the normal value of serum amylase on or after postoperative day 3 Day 3 after operation
Secondary Number of participants developing post-operative morbidity Post-operative complications, graded according to the Clavien-Dindo classification, are recorded 90 days
Secondary Number of participants developing post-operative mortality All cause mortality after operation was recorded 90 days
Secondary Total length of hospital stay of participants The total number of days spent in hospital calculated from the day of admission to discharge for every participant, including the time spent for pre-operative endoscopy and operation 90 days after endoscopy and operation
Secondary Number of participants developing complications related to Endoscopic Retrograde Cholangiography All complications occurred after Endoscopic Retrograde Cholangiopancreatography were recorded 14 days after endoscopy
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