Association Between Preoperative HALP and Immediate Postoperative Outcomes

NCT05506748 | Completed DMC

• 1 other identifier: 078/079-103
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple inflammation-based prognostic scores have been developed for the prediction of perioperative morbidity and mortality following pancreaticoduodenectomy (PD). Preoperative "Hemoglobin, Albumin, Lymphocytes and Platelets index (HALP)" is one of the promising inflammatory markers that has emerged as a predictor of postoperative survival. To date, no study has been done with preoperative HALP to predict 30days morbidity and mortality. Is there any association between Preoperative HALP (hemoglobin, albumin, lymphocyte, and platelet) and 30 days post operative morbidity and mortality in patients undergoing Pancreaticoduodenectomy?

Conditions

Hemoglobins; Albumins; Platelets; Lymphocytes; Morbidity; Mortality; Whipples Procedure

Outcome Measures

Primary Outcomes (5)

• Morbidity- Clavién-Dindo grading :

  It is graded from grade I to V on the basis of surgical site infection, organ space infection, single or multiple organ failure, and death. Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions Grade II Requires pharmacological treatment, blood transfusions, or total parenteral nutrition Grade III Requires surgical, endoscopic, or radiological intervention IIIa Not under general anesthesia IIIb Under general anesthesia Grade IV Life-threatening complication requiring IC/ICU management IVa Single organ dysfunction IVb Multiorgan dysfunction Grade V Death of a patient PS- Higher the score worst the outcome.

  30days following the pancreaticoduodenectomy

• Morbidity- Delayed Gastric Empty (DGE)

  Postoperative gastroparesis. Grade A DGE: If the Naso-Gastric Tube (NGT) is needed between the postoperative day (POD) -4 and 7, or if reinserted due to nausea and vomiting after removal by POD 3 and the patient is unable to tolerate a solid diet on POD 7, but starts a solid diet before POD 14. Grade B DGE: If the NGT is needed from POD 8-14, if reinserted after POD 7, or if the patient cannot tolerate unlimited oral intake by POD 14, but is able to resume a solid diet before POD 21. Grade C DGE: When nasogastric intubation cannot be discontinued or has to be reinserted after POD 14, or if the patient is unable to maintain unlimited oral intake by POD 21. PS- Higher the score worst the outcome.

  30days following the pancreaticoduodenectomy

• Morbidity- Postoperative pancreatic fistula (POPF)

  A POPF is an abnormal communication between the pancreatic ductal epithelium and another epithelial surface containing pancreas-derived enzyme-rich fluid. Biochemical leak (Grade A): Pancreatic fistula often appears well and requires no intervention. Grade B: Pancreatic fistulas occur in patients who generally appear well, but may require parenteral nutrition or interventional fistula drainage for the fistula to heal. Grade C: Pancreatic fistulas, in which patients appear ill and require parenteral nutrition, interventional drainage, and potentially even re-operation for treatment. PS- Higher the score worst the outcome.

  30days following the pancreaticoduodenectomy

• Morbidity- Post pancreatectomy Hemorrhage (PPH)

  Time of onset * Early hemorrhage ( 24 h after the end of the index operation) * Late hemorrhage ( 24 h after the end of the index operation) Location * Intraluminal * Extraluminal Severity of Hemorrhage Mild * Small or medium volume blood loss (from drains, nasogastric tube, or on ultrasonography, decrease in hemoglobin concentration 3 g/dl) * Mild clinical impairment of the patient, no therapeutic consequence, or at most the need for noninvasive treatment with volume resuscitation or blood transfusions (2-3 units packed cells within 24hrs of end of operation or 1-3 units if later than 24hrs after operation) * No need for reoperation or interventional angiographic embolization; endoscopic treatment of anastomotic bleeding may occur provided the other conditions apply Severe * Large volume blood loss (drop in hemoglobin level by 3g/dl) * Clinically significant impairment and need for blood transfusion (3 units packed cells) * Need for invasive treatment.

  30days following the pancreaticoduodenectomy

• Mortality

  Survival within 30days.

  30days following the pancreaticoduodenectomy

Interventions

pantients undergoing pancreaticoduodenectomy OTHER

The study includes all the cases who underwent pancreaticoduodenectomy for carcinoma head of the pancreas, distal cholangiocarcinoma, periampullary and duodenal cancer.

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the cases of elective pancreaticoduodenectomy with combined "Artery First with Posterior and Uncinate approach" for malignant pancreatic head disease (ampullary, HOP, dCCA, duodenal In the Department of Surgery at BPKMCH between April 2021 to April 2022.

You may qualify if:

• \. All the cases of elective pancreaticoduodenectomies for malignant pancreatic head disease

You may not qualify if:

• Incomplete clinicopathological and follow-up data,
• Age \<15 years and age \>80 years
• History of antitumor treatments, and
• Record of other malignant tumors, (unresectable?)

Sponsors & Collaborators

• Chitwan Medical College: lead

Study Sites (1)

Chitwan Medical College Teaching Hospital

Bharatpur, Bagmati, 44207, Nepal

Location

Related Publications (13)

• Ruiz-Tovar J, Martin-Perez E, Fernandez-Contreras ME, Reguero-Callejas ME, Gamallo-Amat C. Impact of preoperative levels of hemoglobin and albumin on the survival of pancreatic carcinoma. Rev Esp Enferm Dig. 2010 Nov;102(11):631-6. doi: 10.4321/s1130-01082010001100003.

  PMID: 21142383 BACKGROUND

• Shirai Y, Shiba H, Haruki K, Horiuchi T, Saito N, Fujiwara Y, Sakamoto T, Uwagawa T, Yanaga K. Preoperative Platelet-to-Albumin Ratio Predicts Prognosis of Patients with Pancreatic Ductal Adenocarcinoma After Pancreatic Resection. Anticancer Res. 2017 Feb;37(2):787-793. doi: 10.21873/anticanres.11378.

  PMID: 28179331 BACKGROUND

• Xu SS, Li S, Xu HX, Li H, Wu CT, Wang WQ, Gao HL, Jiang W, Zhang WH, Li TJ, Ni QX, Liu L, Yu XJ. Haemoglobin, albumin, lymphocyte and platelet predicts postoperative survival in pancreatic cancer. World J Gastroenterol. 2020 Feb 28;26(8):828-838. doi: 10.3748/wjg.v26.i8.828.

  PMID: 32148380 BACKGROUND

• Gao X, Lin B, Lin Q, Ye T, Zhou T, Hu M, Zhu H, Lu F, Chen W, Xia P, Zhang F, Yu Z. A HALP score-based prediction model for survival of patients with the upper tract urothelial carcinoma undergoing radical nephroureterectomy. Bosn J Basic Med Sci. 2022 Apr 1;22(2):280-290. doi: 10.17305/bjbms.2021.6543.

  PMID: 35020581 BACKGROUND

• Guo Y, Shi D, Zhang J, Mao S, Wang L, Zhang W, Zhang Z, Jin L, Yang B, Ye L, Yao X. The Hemoglobin, Albumin, Lymphocyte, and Platelet (HALP) Score is a Novel Significant Prognostic Factor for Patients with Metastatic Prostate Cancer Undergoing Cytoreductive Radical Prostatectomy. J Cancer. 2019 Jan 1;10(1):81-91. doi: 10.7150/jca.27210. eCollection 2019.

  PMID: 30662528 BACKGROUND

• Wang X, He Q, Liang H, Liu J, Xu X, Jiang K, Zhang J. A novel robust nomogram based on preoperative hemoglobin and albumin levels and lymphocyte and platelet counts (HALP) for predicting lymph node metastasis of gastric cancer. J Gastrointest Oncol. 2021 Dec;12(6):2706-2718. doi: 10.21037/jgo-21-507.

  PMID: 35070400 BACKGROUND

• Leetanaporn K, Hanprasertpong J. Predictive Value of the Hemoglobin-Albumin-Lymphocyte-Platelet (HALP) Index on the Oncological Outcomes of Locally Advanced Cervical Cancer Patients. Cancer Manag Res. 2022 Jun 14;14:1961-1972. doi: 10.2147/CMAR.S365612. eCollection 2022.

  PMID: 35726336 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.

  PMID: 19638912 BACKGROUND

• Hoshimoto S, Hishinuma S, Shirakawa H, Tomikawa M, Ozawa I, Ogata Y. Validation and clinical usefulness of pre- and postoperative systemic inflammatory parameters as prognostic markers in patients with potentially resectable pancreatic cancer. Pancreatology. 2020 Mar;20(2):239-246. doi: 10.1016/j.pan.2019.12.004. Epub 2019 Dec 14.

  PMID: 31862230 RESULT

• Afaneh C, Gerszberg D, Slattery E, Seres DS, Chabot JA, Kluger MD. Pancreatic cancer surgery and nutrition management: a review of the current literature. Hepatobiliary Surg Nutr. 2015 Feb;4(1):59-71. doi: 10.3978/j.issn.2304-3881.2014.08.07.

  PMID: 25713805 RESULT

Study Officials

• Harish Neupane, MBBS, MS

  Chitwan Medical Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 18, 2022
• Study Start: April 20, 2021
• Primary Completion: April 20, 2022
• Study Completion: April 20, 2022
• Last Updated: August 18, 2022

Record last verified: 2022-08

Locations

NE (1)