Preoperative Endoscopic Pancreatic Stent for Distal Pancreatectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-21

Study Completion Date

2026-05-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pancreatectomy Pancreatic Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Pre-op Stenting

Pre-operative pancreatic stent inserted by Endoscopic Retrograde Cholangiography, followed by distal pancreatectomy

Group Type EXPERIMENTAL

Pancreatic Stenting

Intervention Type PROCEDURE

Pancreatic stent of appropriate size and length is inserted to the pancreatic duct before distal pancreatectomy

Surgery alone

Distal pancreatectomy alone

Group Type ACTIVE_COMPARATOR

No Stent

Intervention Type PROCEDURE

No preoperative stenting with distal pancreatectomy alone

Interventions

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Pancreatic Stenting

Pancreatic stent of appropriate size and length is inserted to the pancreatic duct before distal pancreatectomy

Intervention Type PROCEDURE

No Stent

No preoperative stenting with distal pancreatectomy alone

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No