Clinical trial NCT05682768: Buttressed Pancreatico-Gastrostomy for Soft Pancreas With Small Diameter Pancreatic Duct in Whipple Procedure
Official title: Buttressed Pancreatico-Gastrostomy for Soft Pancreas With Small Pancreatic Duct Diameter in Whipple Procedure. A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Fistula
Keywords: Cancer pancreas
Pancreaticoduodenectomy
Pancreaticogastrostomy
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 69
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with soft pancreas and pancreatic duct diameter ≤ 5 mm (15 Fr), who underwent the classic pancreaticoduodenectomy (Whipple) procedure for cancer pancreas. Supporting pancreatico-gastrostomy with buttressing sutures was used. It is an anastomotic modification by supporting it with trans-pancreatic and full-thickness gastric wall transverse mattress U- Shaped sutures to fix the posterior gastric wall envelope around the pancreatic stump, to alleviate any tension on the Pancreatico-Gastrostomy sutures.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Post operative Pancreatic Fistula
timeFrame: up to 5 days (from time of surgery to time of detection of post-operative pancreatic fistula)
Secondary outcomes:
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: Qena Faculty of Medicine, South Valley University Hospitals
Study officials:
affiliation: South Valley University, Faculty of Medicine
name: Abdallah M Taha, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Lermite E, Pessaux P, Brehant O, Teyssedou C, Pelletier I, Etienne S, Arnaud JP. Risk factors of pancreatic fistula and delayed gastric emptying after pancreaticoduodenectomy with pancreaticogastrostomy. J Am Coll Surg. 2007 Apr;204(4):588-96. doi: 10.1016/j.jamcollsurg.2007.01.018. Epub 2007 Mar 2.
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