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Completed

NCT Number: NCT05682768

Buttressed Pancreatico-Gastrostomy for Soft Pancreas With Small Diameter Pancreatic Duct in Whipple Procedure

Post-operative pancreatic fistula after Pancreaticoduodenectomy procedure, is still a major complication that might be affected by pancreatic stump reconstruction technique. More than 60 techniques were published in literature. Soft pancreas and small pancreatic duct size were major risk factors for post-operative pancreatic fistula. Supporting Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures is a new and safe technique for decreasing the risk of post-operative pancreatic fistula in high-risk patients.

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Key information

Conditions

Pancreatic Fistula Digestive System Diseases Digestive System Fistula Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Fistula Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Qena Faculty of Medicine, South Valley University Hospitals

Qina, Egypt

About this study

Post-operative pancreatic fistula after Pancreaticoduodenectomy procedure, is still a major complication that might be affected by pancreatic stump reconstruction technique. More than 60 techniques were published in literature. Soft pancreas and small pancreatic duct size were major risk factors for post-operative pancreatic fistula. Supporting Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures is a new and safe technique for decreasing the risk of post-operative pancreatic fistula in high-risk patients.

The authors used this technique in pancreato-gastrostomy. Data were collected, tabulated and analyzed to evaluate the new technique and its impact on the incidence of post-operative pancreatic fistula.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient diagnosed with resectable cancer head pancreas.
  • Soft Pancreas.
  • Small pancreatic duct diameter.

Exclusion criteria

  • Unresectable cancer pancreas.
  • Non soft pancreas.
  • Dilated pancreatic duct.

Treatment and study plan

Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures

Procedure

Adding suporting sutures between th posterior gastric wall and ancreatic stump in whipple procedure, the sutures are Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures.

Other names: Buttressing sutures

Primary outcomes

  1. Post operative Pancreatic Fistula

    Time frame: up to 5 days (from time of surgery to time of detection of post-operative pancreatic fistula)

    Detection of chemical or clinical pancreatic fluid discharge after post-operative day 3.

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Official study title

Buttressed Pancreatico-Gastrostomy for Soft Pancreas With Small Pancreatic Duct Diameter in Whipple Procedure. A Retrospective Cohort Study

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jan 12, 2023
Registry last updated
Jan 12, 2023

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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