4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Perioperative Epidural Block and Dexamethasone in Pancreatic Cancer Surgery

Perioperative Epidural Block and Dexamethasone in Pancreatic Cancer Surgery

Study Description
Brief Summary:
Pancreatic cancer remains a devastating disease with an average 5-year survival rate of about 3-5%. Previous retrospective studies showed that perioperative epidural block and/or dexamethasone are associated with improved outcome after cancer surgery. This randomized trial aims to investigate the effect of perioperative epidural block and/or dexamethasone on long-term survival in patients following pancreatic cancer surgery.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Surgery Epidural Block Dexamethasone Overall Survival Other: Epidural block Drug: Dexamethasone Phase 4

Detailed Description:

Pancreatic cancer is the fourth leading cause of cancer-related death in the world, and is estimated to become the second one in 2030. For patients with resectable pancreatic cancer, radical surgery is the first-line therapy. However, the clinical outcomes remain poor even after radical resection, as the incidence of postoperative morbidity is up to 50% and the 5-year survival rate remains below 30%.

For patients undergoing major intraabdominal surgery, epidural block may provide advantages by blocking the afferent nociceptive stimuli, providing better pain relief, decreasing opioid consumption, and alleviating stress response. These effects may be helpful in preserving immune function. Some retrospective studies showed that epidural block is associated with delayed cancer recurrence/metastasis and improved survival after cancer surgery.

Low-dose dexamethasone is frequently used to prevent postoperative nausea and vomiting. Recent evidences from retrospective studies suggest that perioperative dexamethasone may also affect long-term outcome after cancer surgery. For example, in patients undergoing lung cancer surgery, intraoperative dexamethasone is associated with improved recurrence-free and overall survival. Similar results are also reported in patients after pancreatic cancer surgery.

The investigators hypothesize that perioperative epidural block and dexamethasone may improve survival in patients after radical pancreatic surgery. The purpose of this study is to investigate whether perioperative epidural block and/or dexamethasone can improve 2-year survival in patients after pancreatic cancer surgery.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: 2×2 factorial trial
Masking: Single (Outcomes Assessor)
Masking Description: For dexamethasone administration, all the participants, care providers, investigators, and outcomes assessors are masked. For epidural block, outcome assessors are masked.
Primary Purpose: Supportive Care
Official Title: Effect of Perioperative Epidural Block and Dexamethasone on Outcome of Patients Undergoing Pancreatic Cancer Surgery
Actual Study Start Date : September 11, 2019
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2026
Arms and Interventions
Arm Intervention/treatment
No Intervention: Control
Patients in this group receive general anesthesia, without epidural block and perioperative dexamethasone. Patient-controlled intravenous analgesia is provided after surgery.
Experimental: Epidural block
Patients in this group receive combined epidural-general anesthesia (0.375% ropivacaine for epidural block), without perioperative dexamethasone. Patient-controlled epidural analgesia is provided after surgery.
 Other: Epidural block
Epidural block (with 0.375% ropivacaine) is performed during surgery. Patient-controlled epidural analgesia (with a mixture of 0.12% ropivacaine and 0.5 microgram/ml sufentanyl) is provided after surgery.
Other Name: Epidural anesthesia/analgesia
Experimental: Dexamethasone
Patients in this group receive dexamethasone (10 mg) before anesthesia induction and general anesthesia, without epidural block. Patient-controlled intravenous analgesia is provided after surgery.
 Drug: Dexamethasone
Dexamethasone (10 mg) is administered intravenously before anesthesia induction.
Other Name: Glucocorticoids
Experimental: Epidural block+Dexamethasone
Patients this group receive dexamethasone (10 mg) before anesthesia induction and combined epidural-general anesthesia (0.375% ropivacaine for epidural block). Patient-controlled epidural analgesia is provided after surgery.
 Other: Epidural block
Epidural block (with 0.375% ropivacaine) is performed during surgery. Patient-controlled epidural analgesia (with a mixture of 0.12% ropivacaine and 0.5 microgram/ml sufentanyl) is provided after surgery.
Other Name: Epidural anesthesia/analgesia

Drug: Dexamethasone
Dexamethasone (10 mg) is administered intravenously before anesthesia induction.
Other Name: Glucocorticoids
Outcome Measures
Primary Outcome Measures :
  1. 2-year overall survival [ Time Frame: Up to 2 years after surgery. ]
    2-year overall survival


Secondary Outcome Measures :
  1. Postoperative gastrointestinal complications. [ Time Frame: Up to 30 days after surgery. ]
    Rate of postoperative gastrointestinal complications.

  2. Overall postoperative complications. [ Time Frame: Up to 30 days after surgery. ]
    Rate of overall postoperative complications.

  3. Length of stay in hospital after surgery. [ Time Frame: Up to 30 days after surgery. ]
    Length of stay in hospital after surgery.

  4. All-cause 30-day mortality. [ Time Frame: Up to 30 days after surgery. ]
    Rate of all-cause 30-day mortality.

  5. Quality of life in 1- and 2-year survivors. [ Time Frame: At the end of the first and second year after surgery. ]
    Quality of life is assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionaire (EORTC QLQ)-PAN26. It is a 26-item questionnaire that evaluates 9 symptoms and 5 emotional difficulties related to pancreatic cancer. Each item is scaled 0-100. High scores indicate worse symptoms and poorer quality of life.

  6. Hospital readmission within 2 years after surgery. [ Time Frame: Up to 2 years after surgery. ]
    Rate of hospital readmission within 2 years after surgery.

  7. 2-year progression-free survival [ Time Frame: Up to 2 years after surgery. ]
    Cancer progression is evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1.


Other Outcome Measures:
  1. Subjective sleep quality: Numeric Rating Scale [ Time Frame: Between 8-10 am on the first, second, and third days after surgery. ]
    Subjective sleep quality is assessed with a Numeric Rating Scale (NRS, an 11-point scale where 0 indicates the best sleep and 10 the worst sleep).

  2. Pain severity (at rest and with movement): Numeric Rating Scale [ Time Frame: Between 8-10 am on the first, second, and third days after surgery. ]
    Pain severity is assessed with a Numeric Rating Scale (NRS, an 11-point scale where 0 indicates no pain and 10 the worst pain).

  3. Time to ambulation after surgery. [ Time Frame: Up to 30 days after surgery. ]
    Time to ambulation after surgery.

  4. Time to oral intake after surgery. [ Time Frame: Up to 30 days after surgery. ]
    Time to oral intake after surgery.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   45 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥45 and <90 years;
  2. Clinically diagnosed as resectable or possibly resectable pancreatic cancer and scheduled to undergo radical surgery;
  3. Agreed to receive epidural block and postoperative patient-controlled analgesia;
  4. Agreed to participate in the study and provided written informed consent.

Exclusion Criteria:

  1. Clinical evidence of unresectable pancreatic cancer or plan to undergo biopsy;
  2. Previous surgery for pancreatic cancer, scheduled to undergo resurgery for recurrence or metastasis;
  3. Complicated with primary malignant tumor in other organ(s), either previously or at present;
  4. Complicated with autoimmune diseases, receiving either glucocorticoids or other immunosuppressants before surgery;
  5. Unable to complete preoperative evaluation due to severe dementia, language barrier, coma, or end-stage diseases;
  6. Severe hepatic dysfunction (Child-Pugh C), severe renal insufficiency (serum creatinine >442 µmol/L or requirement of renal replacement therapy), or American Society of Anesthesiologists classification ≥V；
  7. Contradictions to epidural anesthesia, including spinal malformation, history of spinal surgery, coagulation disorder, suspected infection at the site of puncture, or severe low back pain;
  8. Other conditions that are considered unsuitable for study participation;
  9. Refused to participate in the study.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Dong-Xin Wang, MD, PhD 86 (10) 83572784 wangdongxin@hotmail.com
Contact: Zhen-Zhen Xu, MD 86 (10) 83572460 zjxvzhenzhen@126.com

Locations
Layout table for location information
China, Beijing
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Dong-Xin Wang, MD, PhD    86 (10) 83572784    wangdongxin@hotmail.com   
Contact: Zhen-Zhen Xu, MD    86 (10) 83572460    zjxvzhenzhen@126.com   
Sponsors and Collaborators
Peking University First Hospital
Investigators
Layout table for investigator information
Principal Investigator: Dong-Xin Wang, MD, PhD Peking University First Hospital
Tracking Information
First Submitted Date  ICMJE July 16, 2019
First Posted Date  ICMJE July 19, 2019
Last Update Posted Date September 12, 2019
Actual Study Start Date  ICMJE September 11, 2019
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2019) 		2-year overall survival [ Time Frame: Up to 2 years after surgery. ]
2-year overall survival
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2019)
  • Postoperative gastrointestinal complications. [ Time Frame: Up to 30 days after surgery. ]
    Rate of postoperative gastrointestinal complications.
  • Overall postoperative complications. [ Time Frame: Up to 30 days after surgery. ]
    Rate of overall postoperative complications.
  • Length of stay in hospital after surgery. [ Time Frame: Up to 30 days after surgery. ]
    Length of stay in hospital after surgery.
  • All-cause 30-day mortality. [ Time Frame: Up to 30 days after surgery. ]
    Rate of all-cause 30-day mortality.
  • Quality of life in 1- and 2-year survivors. [ Time Frame: At the end of the first and second year after surgery. ]
    Quality of life is assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionaire (EORTC QLQ)-PAN26. It is a 26-item questionnaire that evaluates 9 symptoms and 5 emotional difficulties related to pancreatic cancer. Each item is scaled 0-100. High scores indicate worse symptoms and poorer quality of life.
  • Hospital readmission within 2 years after surgery. [ Time Frame: Up to 2 years after surgery. ]
    Rate of hospital readmission within 2 years after surgery.
  • 2-year progression-free survival [ Time Frame: Up to 2 years after surgery. ]
    Cancer progression is evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 17, 2019)
  • Subjective sleep quality: Numeric Rating Scale [ Time Frame: Between 8-10 am on the first, second, and third days after surgery. ]
    Subjective sleep quality is assessed with a Numeric Rating Scale (NRS, an 11-point scale where 0 indicates the best sleep and 10 the worst sleep).
  • Pain severity (at rest and with movement): Numeric Rating Scale [ Time Frame: Between 8-10 am on the first, second, and third days after surgery. ]
    Pain severity is assessed with a Numeric Rating Scale (NRS, an 11-point scale where 0 indicates no pain and 10 the worst pain).
  • Time to ambulation after surgery. [ Time Frame: Up to 30 days after surgery. ]
    Time to ambulation after surgery.
  • Time to oral intake after surgery. [ Time Frame: Up to 30 days after surgery. ]
    Time to oral intake after surgery.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Perioperative Epidural Block and Dexamethasone in Pancreatic Cancer Surgery
Official Title  ICMJE Effect of Perioperative Epidural Block and Dexamethasone on Outcome of Patients Undergoing Pancreatic Cancer Surgery
Brief Summary Pancreatic cancer remains a devastating disease with an average 5-year survival rate of about 3-5%. Previous retrospective studies showed that perioperative epidural block and/or dexamethasone are associated with improved outcome after cancer surgery. This randomized trial aims to investigate the effect of perioperative epidural block and/or dexamethasone on long-term survival in patients following pancreatic cancer surgery.
Detailed Description

Pancreatic cancer is the fourth leading cause of cancer-related death in the world, and is estimated to become the second one in 2030. For patients with resectable pancreatic cancer, radical surgery is the first-line therapy. However, the clinical outcomes remain poor even after radical resection, as the incidence of postoperative morbidity is up to 50% and the 5-year survival rate remains below 30%.

For patients undergoing major intraabdominal surgery, epidural block may provide advantages by blocking the afferent nociceptive stimuli, providing better pain relief, decreasing opioid consumption, and alleviating stress response. These effects may be helpful in preserving immune function. Some retrospective studies showed that epidural block is associated with delayed cancer recurrence/metastasis and improved survival after cancer surgery.

Low-dose dexamethasone is frequently used to prevent postoperative nausea and vomiting. Recent evidences from retrospective studies suggest that perioperative dexamethasone may also affect long-term outcome after cancer surgery. For example, in patients undergoing lung cancer surgery, intraoperative dexamethasone is associated with improved recurrence-free and overall survival. Similar results are also reported in patients after pancreatic cancer surgery.

The investigators hypothesize that perioperative epidural block and dexamethasone may improve survival in patients after radical pancreatic surgery. The purpose of this study is to investigate whether perioperative epidural block and/or dexamethasone can improve 2-year survival in patients after pancreatic cancer surgery.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:
2×2 factorial trial
Masking: Single (Outcomes Assessor)
Masking Description:
For dexamethasone administration, all the participants, care providers, investigators, and outcomes assessors are masked. For epidural block, outcome assessors are masked.
Primary Purpose: Supportive Care
Condition  ICMJE
  • Pancreatic Cancer
  • Surgery
  • Epidural Block
  • Dexamethasone
  • Overall Survival
Intervention  ICMJE
  • Other: Epidural block
    Epidural block (with 0.375% ropivacaine) is performed during surgery. Patient-controlled epidural analgesia (with a mixture of 0.12% ropivacaine and 0.5 microgram/ml sufentanyl) is provided after surgery.
    Other Name: Epidural anesthesia/analgesia
  • Drug: Dexamethasone
    Dexamethasone (10 mg) is administered intravenously before anesthesia induction.
    Other Name: Glucocorticoids
Study Arms  ICMJE
  • No Intervention: Control
    Patients in this group receive general anesthesia, without epidural block and perioperative dexamethasone. Patient-controlled intravenous analgesia is provided after surgery.
  • Experimental: Epidural block
    Patients in this group receive combined epidural-general anesthesia (0.375% ropivacaine for epidural block), without perioperative dexamethasone. Patient-controlled epidural analgesia is provided after surgery.
    Intervention: Other: Epidural block
  • Experimental: Dexamethasone
    Patients in this group receive dexamethasone (10 mg) before anesthesia induction and general anesthesia, without epidural block. Patient-controlled intravenous analgesia is provided after surgery.
    Intervention: Drug: Dexamethasone
  • Experimental: Epidural block+Dexamethasone
    Patients this group receive dexamethasone (10 mg) before anesthesia induction and combined epidural-general anesthesia (0.375% ropivacaine for epidural block). Patient-controlled epidural analgesia is provided after surgery.
    Interventions:
    • Other: Epidural block
    • Drug: Dexamethasone
Publications *
  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. Erratum in: CA Cancer J Clin. 2020 Jul;70(4):313.
  • Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin. 2018 Jan;68(1):7-30. doi: 10.3322/caac.21442. Epub 2018 Jan 4.
  • Rahib L, Smith BD, Aizenberg R, Rosenzweig AB, Fleshman JM, Matrisian LM. Projecting cancer incidence and deaths to 2030: the unexpected burden of thyroid, liver, and pancreas cancers in the United States. Cancer Res. 2014 Jun 1;74(11):2913-21. doi: 10.1158/0008-5472.CAN-14-0155. Erratum in: Cancer Res. 2014 Jul 15;74(14):4006.
  • Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
  • Chen W, Sun K, Zheng R, Zeng H, Zhang S, Xia C, Yang Z, Li H, Zou X, He J. Cancer incidence and mortality in China, 2014. Chin J Cancer Res. 2018 Feb;30(1):1-12. doi: 10.21147/j.issn.1000-9604.2018.01.01.
  • Kamisawa T, Wood LD, Itoi T, Takaori K. Pancreatic cancer. Lancet. 2016 Jul 2;388(10039):73-85. doi: 10.1016/S0140-6736(16)00141-0. Epub 2016 Jan 30. Review.
  • Yeo CJ, Cameron JL. Prognostic factors in ductal pancreatic cancer. Langenbecks Arch Surg. 1998 Apr;383(2):129-33. Review.
  • Winter JM, Cameron JL, Campbell KA, Arnold MA, Chang DC, Coleman J, Hodgin MB, Sauter PK, Hruban RH, Riall TS, Schulick RD, Choti MA, Lillemoe KD, Yeo CJ. 1423 pancreaticoduodenectomies for pancreatic cancer: A single-institution experience. J Gastrointest Surg. 2006 Nov;10(9):1199-210; discussion 1210-1.
  • Heerkens HD, Tseng DS, Lips IM, van Santvoort HC, Vriens MR, Hagendoorn J, Meijer GJ, Borel Rinkes IH, van Vulpen M, Molenaar IQ. Health-related quality of life after pancreatic resection for malignancy. Br J Surg. 2016 Feb;103(3):257-66. doi: 10.1002/bjs.10032. Epub 2015 Nov 19.
  • Ohtsuka T, Yamaguchi K, Chijiiwa K, Kinukawa N, Tanaka M. Quality of life after pylorus-preserving pancreatoduodenectomy. Am J Surg. 2001 Sep;182(3):230-6.
  • Conroy T, Bachet JB, Ayav A, Huguet F, Lambert A, Caramella C, Maréchal R, Van Laethem JL, Ducreux M. Current standards and new innovative approaches for treatment of pancreatic cancer. Eur J Cancer. 2016 Apr;57:10-22. doi: 10.1016/j.ejca.2015.12.026. Epub 2016 Feb 4. Review.
  • Chae BK, Lee HW, Sun K, Choi YH, Kim HM. The effect of combined epidural and light general anesthesia on stress hormones in open heart surgery patients. Surg Today. 1998;28(7):727-31.
  • Pöpping DM, Elia N, Van Aken HK, Marret E, Schug SA, Kranke P, Wenk M, Tramèr MR. Impact of epidural analgesia on mortality and morbidity after surgery: systematic review and meta-analysis of randomized controlled trials. Ann Surg. 2014 Jun;259(6):1056-67. doi: 10.1097/SLA.0000000000000237. Review.
  • Guay J. The effect of neuraxial blocks on surgical blood loss and blood transfusion requirements: a meta-analysis. J Clin Anesth. 2006 Mar;18(2):124-8.
  • Haughom BD, Schairer WW, Nwachukwu BU, Hellman MD, Levine BR. Does Neuraxial Anesthesia Decrease Transfusion Rates Following Total Hip Arthroplasty? J Arthroplasty. 2015 Sep;30(9 Suppl):116-20. doi: 10.1016/j.arth.2015.01.058. Epub 2015 Jun 3.
  • Waurick R, Van Aken H. Update in thoracic epidural anaesthesia. Best Pract Res Clin Anaesthesiol. 2005 Jun;19(2):201-13. Review.
  • Biki B, Mascha E, Moriarty DC, Fitzpatrick JM, Sessler DI, Buggy DJ. Anesthetic technique for radical prostatectomy surgery affects cancer recurrence: a retrospective analysis. Anesthesiology. 2008 Aug;109(2):180-7. doi: 10.1097/ALN.0b013e31817f5b73.
  • Exadaktylos AK, Buggy DJ, Moriarty DC, Mascha E, Sessler DI. Can anesthetic technique for primary breast cancer surgery affect recurrence or metastasis? Anesthesiology. 2006 Oct;105(4):660-4.
  • Tsui BC, Rashiq S, Schopflocher D, Murtha A, Broemling S, Pillay J, Finucane BT. Epidural anesthesia and cancer recurrence rates after radical prostatectomy. Can J Anaesth. 2010 Feb;57(2):107-12. doi: 10.1007/s12630-009-9214-7.
  • Wuethrich PY, Hsu Schmitz SF, Kessler TM, Thalmann GN, Studer UE, Stueber F, Burkhard FC. Potential influence of the anesthetic technique used during open radical prostatectomy on prostate cancer-related outcome: a retrospective study. Anesthesiology. 2010 Sep;113(3):570-6. doi: 10.1097/ALN.0b013e3181e4f6ec.
  • Wang J, Guo W, Wu Q, Zhang R, Fang J. Impact of Combination Epidural and General Anesthesia on the Long-Term Survival of Gastric Cancer Patients: A Retrospective Study. Med Sci Monit. 2016 Jul 8;22:2379-85.
  • Cummings KC 3rd, Xu F, Cummings LC, Cooper GS. A comparison of epidural analgesia and traditional pain management effects on survival and cancer recurrence after colectomy: a population-based study. Anesthesiology. 2012 Apr;116(4):797-806. doi: 10.1097/ALN.0b013e31824674f6.
  • Gottschalk A, Ford JG, Regelin CC, You J, Mascha EJ, Sessler DI, Durieux ME, Nemergut EC. Association between epidural analgesia and cancer recurrence after colorectal cancer surgery. Anesthesiology. 2010 Jul;113(1):27-34. doi: 10.1097/ALN.0b013e3181de6d0d.
  • Grandhi RK, Lee S, Abd-Elsayed A. The Relationship Between Regional Anesthesia and Cancer: A Metaanalysis. Ochsner J. 2017 Winter;17(4):345-361. Review.
  • Pérez-González O, Cuéllar-Guzmán LF, Soliz J, Cata JP. Impact of Regional Anesthesia on Recurrence, Metastasis, and Immune Response in Breast Cancer Surgery: A Systematic Review of the Literature. Reg Anesth Pain Med. 2017 Nov/Dec;42(6):751-756. doi: 10.1097/AAP.0000000000000662. Review.
  • Giles AJ, Hutchinson MND, Sonnemann HM, Jung J, Fecci PE, Ratnam NM, Zhang W, Song H, Bailey R, Davis D, Reid CM, Park DM, Gilbert MR. Dexamethasone-induced immunosuppression: mechanisms and implications for immunotherapy. J Immunother Cancer. 2018 Jun 11;6(1):51. doi: 10.1186/s40425-018-0371-5.
  • Kunicka JE, Talle MA, Denhardt GH, Brown M, Prince LA, Goldstein G. Immunosuppression by glucocorticoids: inhibition of production of multiple lymphokines by in vivo administration of dexamethasone. Cell Immunol. 1993 Jun;149(1):39-49.
  • Yu HC, Luo YX, Peng H, Kang L, Huang MJ, Wang JP. Avoiding perioperative dexamethasone may improve the outcome of patients with rectal cancer. Eur J Surg Oncol. 2015 May;41(5):667-73. doi: 10.1016/j.ejso.2015.01.034. Epub 2015 Feb 19.
  • Singh PP, Lemanu DP, Taylor MH, Hill AG. Association between preoperative glucocorticoids and long-term survival and cancer recurrence after colectomy: follow-up analysis of a previous randomized controlled trial. Br J Anaesth. 2014 Jul;113 Suppl 1:i68-73. doi: 10.1093/bja/aet577. Epub 2014 Feb 27.
  • Huang WW, Zhu WZ, Mu DL, Ji XQ, Nie XL, Li XY, Wang DX, Ma D. Perioperative Management May Improve Long-term Survival in Patients After Lung Cancer Surgery: A Retrospective Cohort Study. Anesth Analg. 2018 May;126(5):1666-1674. doi: 10.1213/ANE.0000000000002886.
  • Sandini M, Ruscic KJ, Ferrone CR, Warshaw AL, Qadan M, Eikermann M, Lillemoe KD, Fernández-Del Castillo C. Intraoperative Dexamethasone Decreases Infectious Complications After Pancreaticoduodenectomy and is Associated with Long-Term Survival in Pancreatic Cancer. Ann Surg Oncol. 2018 Dec;25(13):4020-4026. doi: 10.1245/s10434-018-6827-5. Epub 2018 Oct 8.
  • Call TR, Pace NL, Thorup DB, Maxfield D, Chortkoff B, Christensen J, Mulvihill SJ. Factors associated with improved survival after resection of pancreatic adenocarcinoma: a multivariable model. Anesthesiology. 2015 Feb;122(2):317-24. doi: 10.1097/ALN.0000000000000489.
  • Katayama H, Kurokawa Y, Nakamura K, Ito H, Kanemitsu Y, Masuda N, Tsubosa Y, Satoh T, Yokomizo A, Fukuda H, Sasako M. Extended Clavien-Dindo classification of surgical complications: Japan Clinical Oncology Group postoperative complications criteria. Surg Today. 2016 Jun;46(6):668-85. doi: 10.1007/s00595-015-1236-x. Epub 2015 Aug 20.
  • Fitzsimmons D, Johnson CD, George S, Payne S, Sandberg AA, Bassi C, Beger HG, Birk D, Büchler MW, Dervenis C, Fernandez Cruz L, Friess H, Grahm AL, Jeekel J, Laugier R, Meyer D, Singer MW, Tihanyi T. Development of a disease specific quality of life (QoL) questionnaire module to supplement the EORTC core cancer QoL questionnaire, the QLQ-C30 in patients with pancreatic cancer. EORTC Study Group on Quality of Life. Eur J Cancer. 1999 Jun;35(6):939-41.
  • Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
  • Wente MN, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Traverso LW, Yeo CJ, Büchler 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.
  • 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. Review.
  • Koch M, Garden OJ, Padbury R, Rahbari NN, Adam R, Capussotti L, Fan ST, Yokoyama Y, Crawford M, Makuuchi M, Christophi C, Banting S, Brooke-Smith M, Usatoff V, Nagino M, Maddern G, Hugh TJ, Vauthey JN, Greig P, Rees M, Nimura Y, Figueras J, DeMatteo RP, Büchler MW, Weitz J. Bile leakage after hepatobiliary and pancreatic surgery: a definition and grading of severity by the International Study Group of Liver Surgery. Surgery. 2011 May;149(5):680-8. doi: 10.1016/j.surg.2010.12.002. Epub 2011 Feb 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 17, 2019) 		260
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2026
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥45 and <90 years;
  2. Clinically diagnosed as resectable or possibly resectable pancreatic cancer and scheduled to undergo radical surgery;
  3. Agreed to receive epidural block and postoperative patient-controlled analgesia;
  4. Agreed to participate in the study and provided written informed consent.

Exclusion Criteria:

  1. Clinical evidence of unresectable pancreatic cancer or plan to undergo biopsy;
  2. Previous surgery for pancreatic cancer, scheduled to undergo resurgery for recurrence or metastasis;
  3. Complicated with primary malignant tumor in other organ(s), either previously or at present;
  4. Complicated with autoimmune diseases, receiving either glucocorticoids or other immunosuppressants before surgery;
  5. Unable to complete preoperative evaluation due to severe dementia, language barrier, coma, or end-stage diseases;
  6. Severe hepatic dysfunction (Child-Pugh C), severe renal insufficiency (serum creatinine >442 µmol/L or requirement of renal replacement therapy), or American Society of Anesthesiologists classification ≥V；
  7. Contradictions to epidural anesthesia, including spinal malformation, history of spinal surgery, coagulation disorder, suspected infection at the site of puncture, or severe low back pain;
  8. Other conditions that are considered unsuitable for study participation;
  9. Refused to participate in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dong-Xin Wang, MD, PhD 86 (10) 83572784 wangdongxin@hotmail.com
Contact: Zhen-Zhen Xu, MD 86 (10) 83572460 zjxvzhenzhen@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04025840
Other Study ID Numbers  ICMJE 2019-99
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dong-Xin Wang, Peking University First Hospital
Study Sponsor  ICMJE Peking University First Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dong-Xin Wang, MD, PhD Peking University First Hospital
PRS Account Peking University First Hospital
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

治疗案例

前沿医讯