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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05657327
Other study ID # 126059
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2014
Est. completion date September 30, 2023

Study information

Verified date December 2022
Source West China Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In recent years, with the continuous development of minimally invasive techniques, laparoscopic pancreatic surgery has also been widely used. Although the postoperative mortality rate of laparoscopic pancreatic surgery has been decreasing as the technology continues to improve and mature, the complication rate reported varies widely among centers.The definition and grading criteria of ISGPS on postoperative complications of pancreatic surgery are mostly proposed based on open pancreatic surgery, and most of the data of the later related studies are also for open pancreatic surgery, while the applicability of the definition and grading criteria in laparoscopic pancreatic surgery is still lacking in systematic The study The main purpose of this study is to investigate the applicability of the ISGPS definition and grading criteria for pancreatic fistula, postoperative bleeding and delayed gastric emptying in laparoscopic pancreatic surgery.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1000
Est. completion date September 30, 2023
Est. primary completion date July 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: 1. All patients underwent laparoscopic pancreatic resections at the Department of Pancreatic Surgery of West China Hospital of Sichuan University and the Department of Minimal Invasive Surgery of Shangjin Nanfu Hospital between January 2014 and July 2022. 2. All patients underwent laparoscopic pancreaticoduodenectomy (LPD), laparoscopic distal pancreatectomy (LDP), laparoscopic enucleation, laparoscopic middle pancreatectomy (LMP), laparoscopic duodenum-preserving resection of head of pancreas (LDPRHP), or laparoscopic Frey procedure. 3. Patients whose demographic parameters, perioperative clinical variables, postoperative follow-up outcomes for 3 months and total hospital costs can be collected completely. Exclusion Criteria: 1. Patients converted to laparotomy 2. Patients underwent total pancreatectomy 3. Patients underwent pancreatic pseudocyst drainage management 4. Patients underwent pancreas biopsy

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
West China Hospital

References & Publications (10)

Bassi C, Butturini G, Molinari E, Mascetta G, Salvia R, Falconi M, Gumbs A, Pederzoli P. Pancreatic fistula rate after pancreatic resection. The importance of definitions. Dig Surg. 2004;21(1):54-9. doi: 10.1159/000075943. Epub 2003 Dec 30. — View Citation

Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. S — View Citation

Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe — View Citation

Hackert T, Hinz U, Pausch T, Fesenbeck I, Strobel O, Schneider L, Fritz S, Buchler MW. Postoperative pancreatic fistula: We need to redefine grades B and C. Surgery. 2016 Mar;159(3):872-7. doi: 10.1016/j.surg.2015.09.014. Epub 2015 Oct 23. — View Citation

Hassenpflug M, Hinz U, Strobel O, Volpert J, Knebel P, Diener MK, Doerr-Harim C, Werner J, Hackert T, Buchler MW. Teres Ligament Patch Reduces Relevant Morbidity After Distal Pancreatectomy (the DISCOVER Randomized Controlled Trial). Ann Surg. 2016 Nov;26 — View Citation

Maggino L, Malleo G, Bassi C, Allegrini V, McMillan MT, Borin A, Chen B, Drebin JA, Ecker BL, Fraker DL, Lee MK, Paiella S, Roses RE, Salvia R, Vollmer CM Jr. Decoding Grade B Pancreatic Fistula: A Clinical and Economical Analysis and Subclassification Pr — View Citation

Pratt WB, Maithel SK, Vanounou T, Huang ZS, Callery MP, Vollmer CM Jr. Clinical and economic validation of the International Study Group of Pancreatic Fistula (ISGPF) classification scheme. Ann Surg. 2007 Mar;245(3):443-51. doi: 10.1097/01.sla.0000251708. — View Citation

Pulvirenti A, Marchegiani G, Pea A, Allegrini V, Esposito A, Casetti L, Landoni L, Malleo G, Salvia R, Bassi C. Clinical Implications of the 2016 International Study Group on Pancreatic Surgery Definition and Grading of Postoperative Pancreatic Fistula on — View Citation

Wente MN, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Traverso LW, Yeo CJ, Buchler MW. Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the International Study Group of Pan — View Citation

Wente MN, Veit JA, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Yeo CJ, Buchler MW. Postpancreatectomy hemorrhage (PPH): an International Study Group of Pancreatic Surgery (ISGPS) definition. Surgery. 2007 J — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Length of hospitalization Including the patient's perioperative hospital stay, postoperative time to discharge, and length of stay in the ICU Entire perioperative period
Primary Medical expenses Including the entire hospitalization period, medicine, surgery, etc. Entire perioperative period
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