Association Between Preoperative HALP and Immediate Postoperative Outcomes

NCT ID: NCT05506748

Last Updated: 2022-08-18

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

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-20

Study Completion Date

2022-04-20

Brief Summary

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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?

Detailed Description

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General Objective:

To assess the association between preoperative HALP and immediate postoperative outcome among patients undergoing PD.

Specific Objectives:

1. To identify the magnitude of immediate post-operative morbidity and mortality in patients undergoing PD.
2. To evaluate the descriptive measurement of preoperative Hemoglobin, Albumin, Lymphocytes, Platelets and HALP among patients undergoing PD.
3. To compare the preoperative HALP with morbidity and mortality among patients undergoing PD.

Operational Definition:

1. Immediate postoperative time - was taken as 30days following surgery.
2. Morbidity- was defined by Clavién-Dindo20 grading for the surgical complication and DGE,21 POPF,22 and PPH23 -according to International Study Group of Pancreatic Surgery (ISGPS) grading.
3. Mortality- survival within 30days.
4. Level of preoperative HALP- normality test was done via SPSS and data of HALP followed normal Gaussian distribution. So, mean was used for the calculation of cut off value as 35.83. And, patients were divided into low HALP (≤35.83) group and high HALP (\>35.83) group respectively

Conditions

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Hemoglobins Albumins Platelets Lymphocytes Morbidity Mortality Whipples Procedure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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pantients undergoing pancreaticoduodenectomy

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Incomplete clinicopathological and follow-up data,
2. Age \<15 years and age \>80 years
3. History of antitumor treatments, and
4. Record of other malignant tumors, (unresectable?)
Minimum Eligible Age

15 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chitwan Medical College

OTHER

Sponsor Role lead

Responsible Party

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Gaurav Katwal

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Harish Neupane, MBBS, MS

Role: STUDY_CHAIR

Chitwan Medical Hospital

Locations

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Chitwan Medical College Teaching Hospital

Bharatpur, Bagmati, Nepal

Site Status

Countries

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Nepal

References

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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.

Reference Type BACKGROUND
PMID: 21142383 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28179331 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32148380 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35020581 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30662528 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35070400 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35726336 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28040257 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17629996 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17981197 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19638912 (View on PubMed)

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.

Reference Type RESULT
PMID: 31862230 (View on PubMed)

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.

Reference Type RESULT
PMID: 25713805 (View on PubMed)

Other Identifiers

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078/079-103

Identifier Type: -

Identifier Source: org_study_id

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