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NCT Number: NCT07093996

Endoscopic Pancreatic Duct Stent Placement Versus Conventional Approach in the Treatment of Early Phase Acute Pancreatitis

The planned multicenter randomized study is aimed to assess the efficacy and safety of endoscopic pancreatic duct stenting in adult patients with acute pancreatitis. It is planned to include patients with early-stage nonbiliary pancreatitis in the study.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of General Surgery, Sir Run Run Shaw Hospital, Hangzhou, China

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About this study

Endoscopic pancreatic duct stent placement is used to treat a variety of pancreatic diseases, including chronic pancreatitis, Wirsung duct strictures, pseudocysts in disconnected duct syndrome and as a preventive measure after endoscopic retrograde cholangiopancreatography. Despite the obvious progress, the greatest number of unsolved problems remain in the issues of using this manipulation in patients with acute pancreatitis. In particular, the perspectives of the pancreatic duct stent placement in treatment of acute pancreatitis early stages remain controversial.

On the one hand, the installation of a stent in the early acute pancreatitis stages helps to normalize the outflow of pancreatic juice from the pancreas and reduce intraductal pressure, leading to a beneficial effect, as evidenced by a number of researchers. On the other hand, stent placement may partially block the second-order pancreatic ducts or increase the risk of sterile pancreatitis contamination due to the development of reflux. In addition, one should not forget about a number of post-manipulation complications inherent in this procedure, including bleeding from the area of the major duodenal papilla, perforation of the duodenum, progression of pancreatic necrosis and cholangitis. Finally, the timing and indications for early endoscopic stenting of the pancreatic duct are not currently standardized, largely due to the fact that acute pancreatitis is a pathological condition that is difficult to predict.

Thus, although this manipulation seems perspective, due to the lack of evidence base, it is currently difficult to recommend it for use in wide clinical practice.

The planned multicenter randomized study is aimed to assess the efficacy and safety of endoscopic pancreatic duct stenting in adult patients with acute pancreatitis. It is planned to include patients with early-stage nonbiliary pancreatitis in the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of acute pancreatitis confirmed on the basis of at least 2 of the 3 diagnostic criteria according to the revised Atlanta classification
  • Presence of organ failure signs (moderate and severe pancreatitis)
  • Informed consent of the patient

Exclusion criteria

  • Presence of other indications for endoscopic intervention on the major duodenal papilla (biliary pancreatitis with cholangitis, calculus of the major duodenal papilla, stenosis of the major duodenal papilla, etc.)
  • Previous surgical interventions on the major duodenal papilla
  • Diverticula of the major duodenal papilla
  • Pregnancy
  • Shock
  • Coagulopathy (INR>1.5, blood platelets < 50*109/l

Treatment and study plan

Endoscopic pancreatic duct stent placement

Procedure

Endoscopic pancreatic duct stent placement will be performed with a 5Fr Boston Scientific pancreatic stent (3-4 cm in length) within 24 hours from the randomization procedure. The stent will be removed on the 5th day after installation.

Other names: Wirsung stenting

Conventional treatment of acute pancreatitis in early phase

Drug

Infusion therapy, pain relief, nutritional support and surgical procedure if needed

Other names: Conservative treatment

Primary outcomes

  1. Mortality rate

    Time frame: From enrollment to the end of treatment at 3 months

    Data will be tabulated and statistically analyzed in terms of percentages

Secondary outcomes

  1. Incidence of complications associated with endoscopic pancreatic duct stent placement

    Time frame: From endoscopic pancreatic duct stent placement to 3 months

    Frequency of duodenal bleeding, duodenal perforation, unsuccessful major duodenal papilla canulation etc. Data will be tabulated and statistically analyzed in terms of percentages

  2. Rate of different pancreatic necrosis models

    Time frame: From enrollment to the 7th day of treatment

    Will be evaluated according CT-imaging:

    Model 1 - volume of pancreatic necrosis < 30%, or not determined Model 2 - volume of pancreatic necrosis 30-50%, located in the distal pancreatic part Model 3 - volume of pancreatic necrosis 30-50% located in the proximal part Model 4 - volume of pancreatic necrosis 30-50% and more with separation of viable proximal and distal parts (disconnected duct syndrome) Data will be tabulated and statistically analyzed in terms of percentages

  3. Average Balthazar computed tomography severity index (0-10)

    Time frame: From enrollment to the 7th day of treatment

    A scoring system used to assess the severity of acute pancreatitis based on computed tomography scans. Data will be tabulated and statistically analyzed in terms of mean.

  4. Average SOFA (Sequential Organ Failure Assessment Score) score (0-24)

    Time frame: From enrollment to the 7th day of treatment

    Sequential Organ Failure Assessment Score. Data will be tabulated and statistically analyzed in terms of mean

  5. Incidence of other surgical interventions

    Time frame: From enrollment to the end of treatment at 3 months

    Frequency of other surgical interventions, such as abdominal drainage, retroperitoneal drainage, lumbotomy, laparotomy. Data will be tabulated and statistically analyzed in terms of percentages

  6. Number of participants with other surgical interventions

    Time frame: From enrollment to the end of treatment at 3 months

    Number of other surgical interventions, such as abdominal drainage, retroperitoneal drainage, lumbotomy, laparotomy

  7. Length of hospital stay

    Time frame: From date of hospitalization until the date of discharge, assessed up to 3 months

    Data will be tabulated and statistically analyzed in terms of length of hospital stay in days

  8. Number of participants with manifestation of diabetes mellitus

    Time frame: From enrollment to the end of treatment at 3 months

    Data will be tabulated and statistically analyzed in terms of percentages

Study contacts

Contact information is provided by the study sponsor or research team.

Badri V Sigua, PhD

CONTACT

[email protected]

89111979343

Pavel A Kotkov, MD

CONTACT

[email protected]

89062619231

Sponsors and collaborators

Lead sponsor

Almazov National Medical Research Centre

Other

Registry information

Official study title

Endoscopic Pancreatic Duct Stent Placement Versus Conventional Approach in the Treatment of Early Phase Acute Pancreatitis: International Multicenter Controlled Randomized Prospective Study Protocol

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 30, 2025
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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