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

NCT ID: NCT05682768

Last Updated: 2023-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2022-12-25

Brief Summary

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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

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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.

Conditions

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Pancreatic Fistula

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients

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

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

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Buttressing sutures

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South Valley University

OTHER

Sponsor Role lead

Responsible Party

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Abdallah Mohamed Taha Aly

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abdallah M Taha, MD

Role: PRINCIPAL_INVESTIGATOR

South Valley University, Faculty of Medicine

Locations

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Qena Faculty of Medicine, South Valley University Hospitals

Qina, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 18496727 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19917946 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22233940 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23122535 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19461951 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17382217 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16327486 (View on PubMed)

Other Identifiers

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SVU-MED-SUR011-4-22-10-465

Identifier Type: -

Identifier Source: org_study_id

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