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

NCT05682768 | Completed

• 1 other identifier: SVU-MED-SUR011-4-22-10-465
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Fistula

Keywords

Cancer pancreas; Pancreaticoduodenectomy; Pancreaticogastrostomy

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Patients

Patients with cancer pancreas with soft pancreas and non-dilated pancreatic duct

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

Interventions

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.

Also known as: Buttressing sutures

Patients

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

Qena Faculty of Medicine, South Valley University Hospitals

Qina, Egypt

Location

Related Publications (7)

• 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.

  PMID: 18496727 BACKGROUND

• 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.

  PMID: 19917946 BACKGROUND

• 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.

  PMID: 22233940 BACKGROUND

• 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.

  PMID: 23122535 BACKGROUND

• 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.

  PMID: 19461951 BACKGROUND

• 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.

  PMID: 17382217 BACKGROUND

• 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.

  PMID: 16327486 BACKGROUND

MeSH Terms

Conditions

Pancreatic Fistula; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Abdallah M Taha, MD

  South Valley University, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: January 12, 2023
• Study Start: January 1, 2018
• Primary Completion: November 30, 2022
• Study Completion: December 25, 2022
• Last Updated: January 12, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)