Application and Optimization of the International Study Group of Pancreatic Surgery (ISGPS) Definition and Grading Criteria for Postoperative Complications of Pancreatic Surgery in Laparoscopic Pancreatic Surgery

NCT05657327 | Unknown

• 1 other identifier: 126059
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Laparoscopic Pancreatic Surgery; Pancreatic Fistula; Postoperative Bleeding; Delayed Gastric Emptying

Outcome Measures

Primary Outcomes (2)

• Length of hospitalization

  Including the patient's perioperative hospital stay, postoperative time to discharge, and length of stay in the ICU

  Entire perioperative period

• Medical expenses

  Including the entire hospitalization period, medicine, surgery, etc.

  Entire perioperative period

Study Arms (2)

Group with postoperative complications

Postoperative complications such as pancreatic fistula, postoperative bleeding and delayed gastric emptying

Group without postoperative complications

No postoperative complications such as pancreatic fistula, postoperative bleeding and delayed gastric emptying

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.
• 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.
• Patients whose demographic parameters, perioperative clinical variables, postoperative follow-up outcomes for 3 months and total hospital costs can be collected completely.

You may not qualify if:

• Patients converted to laparotomy
• Patients underwent total pancreatectomy
• Patients underwent pancreatic pseudocyst drainage management
• Patients underwent pancreas biopsy

Sponsors & Collaborators

• West China Hospital: lead

Related Publications (10)

• 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. Surgery. 2005 Jul;138(1):8-13. doi: 10.1016/j.surg.2005.05.001.

  PMID: 16003309 RESULT

• 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.

  PMID: 14707394 RESULT

• 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 KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CM, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28.

  PMID: 28040257 RESULT

• 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.0000251708.70219.d2.

  PMID: 17435552 RESULT

• 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.

  PMID: 26603847 RESULT

• 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;264(5):723-730. doi: 10.1097/SLA.0000000000001913.

  PMID: 27455155 RESULT

• 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 Proposal. Ann Surg. 2019 Jun;269(6):1146-1153. doi: 10.1097/SLA.0000000000002673.

  PMID: 31082914 RESULT

• 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 Jul;142(1):20-5. doi: 10.1016/j.surg.2007.02.001.

  PMID: 17629996 RESULT

• 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 Pancreatic Surgery (ISGPS). Surgery. 2007 Nov;142(5):761-8. doi: 10.1016/j.surg.2007.05.005.

  PMID: 17981197 RESULT

• 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 775 Consecutive Pancreatic Resections. Ann Surg. 2018 Dec;268(6):1069-1075. doi: 10.1097/SLA.0000000000002362.

  PMID: 28678062 RESULT

MeSH Terms

Conditions

Pancreatic Fistula; Postoperative Hemorrhage; Gastroparesis

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Pancreatic Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Hemorrhage; Pathologic Processes; Postoperative Complications; Stomach Diseases; Gastrointestinal Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: December 10, 2022
• First Posted: December 20, 2022
• Study Start: January 1, 2014
• Primary Completion: July 30, 2021
• Study Completion: September 30, 2023
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR