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

Pancreatic Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05682768
• Other study ID #: SVU-MED-SUR011-4-22-10-465
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 25, 2022

Study information

• Verified date: December 2022
• Source: South Valley University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: December 25, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fistula
• Pancreatic Fistula

Intervention

Procedure:
• Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures
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.

Locations

Country	Name	City	State
Egypt	Qena Faculty of Medicine, South Valley University Hospitals	Qina

Sponsors (1)

Lead Sponsor	Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

References & Publications (7)

Bassi C, Falconi M, Molinari E, Salvia R, Butturini G, Sartori N, Mantovani W, Pederzoli P. Reconstruction by pancreaticojejunostomy versus pancreaticogastrostomy following pancreatectomy: results of a comparative study. Ann Surg. 2005 Dec;242(6):767-71, discussion 771-3. doi: 10.1097/01.sla.0000189124.47589.6d. — View Citation

Callery MP, Pratt WB, Kent TS, Chaikof EL, Vollmer CM Jr. A prospectively validated clinical risk score accurately predicts pancreatic fistula after pancreatoduodenectomy. J Am Coll Surg. 2013 Jan;216(1):1-14. doi: 10.1016/j.jamcollsurg.2012.09.002. Epub 2012 Nov 2. — View Citation

Callery MP, Pratt WB, Vollmer CM Jr. Prevention and management of pancreatic fistula. J Gastrointest Surg. 2009 Jan;13(1):163-73. doi: 10.1007/s11605-008-0534-7. Epub 2008 May 22. — View Citation

Lai EC, Lau SH, Lau WY. Measures to prevent pancreatic fistula after pancreatoduodenectomy: a comprehensive review. Arch Surg. 2009 Nov;144(11):1074-80. doi: 10.1001/archsurg.2009.193. — View 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. — View Citation

Osada S, Imai H, Sasaki Y, Tanaka Y, Nonaka K, Yoshida K. Reconstruction method after pancreaticoduodenectomy. Idea to prevent serious complications. JOP. 2012 Jan 10;13(1):1-6. — View Citation

Schmidt CM, Choi J, Powell ES, Yiannoutsos CT, Zyromski NJ, Nakeeb A, Pitt HA, Wiebke EA, Madura JA, Lillemoe KD. Pancreatic fistula following pancreaticoduodenectomy: clinical predictors and patient outcomes. HPB Surg. 2009;2009:404520. doi: 10.1155/2009/404520. Epub 2009 May 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative Pancreatic Fistula	Detection of chemical or clinical pancreatic fluid discharge after post-operative day 3.	up to 5 days (from time of surgery to time of detection of post-operative pancreatic fistula)