Clinical trial NCT05688137: Abdominal Drainage in the Postoperative Period of Liver Transplantation (DRALIT)
Official title: Abdominal Drainage in the Postoperative Period of Liver Transplantation (DRALIT): Multi-institutional Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Transplant; Complications
Drainage
Lead sponsor: Hospital Universitario Virgen de la Arrixaca
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups of equal size, total n = 365 patients. Simple intraoperative randomization prior to closure of the abdominal wall after fulfilling all the inclusion criteria and none of the exclusion criteria.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Classically, in the postoperative period of liver transplantation (LT), abdominal drainage has been used as a way to make the early diagnosis of hemorrhages, bile leaks and other postsurgical complications, as well as an evacuation route for ascites. The use of it routinely is currently under discussion due to the morbidities associated with its use.

Detailed description: LT has become in recent years a procedure with an increasing number of indications and with a greater number of donations given the social knowledge of the donation process and donation in controlled asystole. The Spanish Registry of Liver Transplantation (RETH) shows a total of 28,609 TH in the period 1986-2019, which represents an average of 867 TH per year in Spain. These data place Spain among the first countries in terms of HT.

In LT, abdominal drainage has historically been used prophylactically as a way to identify early intra-abdominal postoperative complications such as hemorrhage, bile leakage, and others.

In transplant patients, the use of post-surgical abdominal drains on a routine basis has shown an increase in total protein losses in patients with refractory ascites, an increase in ascending infections secondary to drainage, infection and pain at the insertion point of the drain, as well as as, an increase in hospital stay. Nor can a higher rate of postsurgical bleeding and bile leakage be ruled out in patients with abdominal drainage.

Currently, in the few studies that there are in reference to the systematic use of abdominal drains in lTH, the need for them prophylactically is being discussed as an early diagnosis of postoperative intra-abdominal complications is not observed, but complications are seen to increase secondary to drainage. Therefore, the need to use it systematically in all patients is currently under discussion.

Currently, is facing an increase in ERASⓇ (Enhanced Recovery After Surgey) programs, which began in 2008 with colorectal surgery and are currently expanding to other surgical procedures. These programs advocate reducing the number of drains and even not using them in patients with a low risk of post-surgical complications.

In the current bibliography, the methodology of the studies is varied, with the majority being non-randomized retrospective studies, which is why it is a subject that requires studies with a better methodological design and a higher number of patients to obtain conclusions of clinical relevance. that can set the direction in this area that is in constant discussion.

Given the absence of any randomized non-inferiority clinical trial that studies the routine use of abdominal drainage in the postoperative period of liver transplantation, consider that it is necessary to carry it out to increase the evidence.

The number of HT performed in each center is limited and variable annually, which is why consider that the best design for this clinical trial is a European multicenter.

Eligibility criteria: Inclusion Criteria:

* Patients of both sexes aged between 18 and 75 years included in the waiting list for HT by the committee of the Virgen de la Arrixaca University Hospital.
* Sign Informed Consent.

Exclusion Criteria:

* Having been rejected for liver transplantation by said committee.
* Age less than 18 years or greater than 75.
* Any contraindication by the main surgeon that makes the placement of an intra-abdominal drain necessary.
* Not having signed the Informed Consent.

Primary outcomes:
measure: Abdominal drainage complications
timeFrame: 90 days
Secondary outcomes:
measure: Assessment of quality of life (QoL) during the perioperative process using the SF-36 questionnaire.
timeFrame: 120 days
measure: Evaluation of in-hospital stay after surgery.
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Universitario Virgen de la Arrixaca
name: Álvaro Cerezuela Fernández de Palencia
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hobeika C, Cauchy F, Weiss E, Chopinet S, Sepulveda A, Dondero F, Khoy-Ear L, Grigoresco B, Dokmak S, Durand F, Le Roy B, Paugam-Burtz C, Soubrane O. Practical model to identify liver transplant recipients at low risk of postoperative haemorrhage, bile leakage and ascites. BJS Open. 2021 Jan 8;5(1):zraa031. doi: 10.1093/bjsopen/zraa031.
citation: Schwarz C, Soliman T, Gyori G, Silberhumer G, Schoppmann SF, Muhlbacher F, Berlakovich GA. Abdominal drainage after liver transplantation from deceased donors. Langenbecks Arch Surg. 2015 Oct;400(7):813-9. doi: 10.1007/s00423-015-1338-3. Epub 2015 Sep 4.
citation: Rodriguez-Laiz GP, Melgar-Requena P, Alcazar-Lopez CF, Franco-Campello M, Villodre-Tudela C, Pascual-Bartolome S, Bellot-Garcia P, Rodriguez-Soler M, Miralles-Macia CF, Mas-Serrano P, Navarro-Martinez JA, Martinez-Adsuar FJ, Gomez-Salinas L, Jaime-Sanchez FA, Perdiguero-Gil M, Diaz-Cuevas M, Palazon-Azorin JM, Such-Ronda J, Lluis-Casajuana F, Ramia-Angel JM. Fast-Track Liver Transplantation: Six-year Prospective Cohort Study with an Enhanced Recovery After Surgery (ERAS) Protocol. World J Surg. 2021 May;45(5):1262-1271. doi: 10.1007/s00268-021-05963-2. Epub 2021 Feb 23.
citation: Gurusamy KS, Naik P, Davidson BR. Routine drainage for orthotopic liver transplantation. Cochrane Database Syst Rev. 2011 Jun 15;(6):CD008399. doi: 10.1002/14651858.CD008399.pub2.
citation: Arita J, Sakamaki K, Saiura A, Konishi M, Sakamoto Y, Hashimoto M, Sano T, Uesaka K, Kokudo N, Yamanaka T, Shimada K. Drain Placement After Uncomplicated Hepatic Resection Increases Severe Postoperative Complication Rate: A Japanese Multi-institutional Randomized Controlled Trial (ND-trial). Ann Surg. 2021 Feb 1;273(2):224-231. doi: 10.1097/SLA.0000000000004051.
citation: Weiss S, Messner F, Huth M, Weissenbacher A, Denecke C, Aigner F, Brandl A, Dziodzio T, Sucher R, Boesmueller C, Oellinger R, Schneeberger S, Oefner D, Pratschke J, Biebl M. Impact of abdominal drainage systems on postoperative complication rates following liver transplantation. Eur J Med Res. 2015 Aug 21;20(1):66. doi: 10.1186/s40001-015-0163-z.
citation: Brustia R, Monsel A, Skurzak S, Schiffer E, Carrier FM, Patrono D, Kaba A, Detry O, Malbouisson L, Andraus W, Vandenbroucke-Menu F, Biancofiore G, Kaido T, Compagnon P, Uemoto S, Rodriguez Laiz G, De Boer M, Orloff S, Melgar P, Buis C, Zeillemaker-Hoekstra M, Usher H, Reyntjens K, Baird E, Demartines N, Wigmore S, Scatton O. Guidelines for Perioperative Care for Liver Transplantation: Enhanced Recovery After Surgery (ERAS) Recommendations. Transplantation. 2022 Mar 1;106(3):552-561. doi: 10.1097/TP.0000000000003808.
citation: Tang R, Yu LH, Han JW, Lin JY, An JJ, Lu Q. Abdominal drainage systems in modified piggyback orthotopic liver transplantation. Hepatobiliary Pancreat Dis Int. 2021 Feb;20(1):99-102. doi: 10.1016/j.hbpd.2020.09.003. Epub 2020 Sep 13. No abstract available.
citation: Fernandez-Aguilar JL, Suarez Munoz MA, Santoyo Santoyo J, Sanchez-Perez B, Perez-Daga JA, Aranda Narvaez JM, Ramirez Plaza C, Becerra Ortiz R, Titos Garcia A, Gonzalez Sanchez A, Montiel Casado C. Is liver transplantation without abdominal drainage safe? Transplant Proc. 2010 Mar;42(2):647-8. doi: 10.1016/j.transproceed.2010.02.007.
citation: Fernandez-Aguilar JL, Suarez-Munoz MA, Sanchez-Perez B, Gamez Cordoba E, Pulido Roa Y, Aranda Narvaez J, Perez Daga A, Montiel Casado C, Gonzalez Sanchez A, Santoyo Santoyo J. Liver transplantation without abdominal drainage. Transplant Proc. 2012 Nov;44(9):2542-4. doi: 10.1016/j.transproceed.2012.09.039.
citation: Liu CL, Fan ST, Lo CM, Wong Y, Ng IO, Lam CM, Poon RT, Wong J. Abdominal drainage after hepatic resection is contraindicated in patients with chronic liver diseases. Ann Surg. 2004 Feb;239(2):194-201. doi: 10.1097/01.sla.0000109153.71725.8c.
citation: Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
citation: Petrowsky H, Demartines N, Rousson V, Clavien PA. Evidence-based value of prophylactic drainage in gastrointestinal surgery: a systematic review and meta-analyses. Ann Surg. 2004 Dec;240(6):1074-84; discussion 1084-5. doi: 10.1097/01.sla.0000146149.17411.c5.
citation: de Rougemont O, Dutkowski P, Weber M, Clavien PA. Abdominal drains in liver transplantation: useful tool or useless dogma? A matched case-control study. Liver Transpl. 2009 Jan;15(1):96-101. doi: 10.1002/lt.21676.
citation: Sanada Y, Mizuta K, Urahashi T, Umehara M, Wakiya T, Okada N, Hayashida M, Egami S, Hishikawa S, Kawano Y, Ushijima K, Otomo S, Sakamoto K, Fujiwara T, Sakuma Y, Hyodo M, Yasuda Y, Kawarasaki H. Management of intra-abdominal drain after living donor liver transplantation. Transplant Proc. 2010 Dec;42(10):4555-9. doi: 10.1016/j.transproceed.2010.09.159.
citation: Baldini E, Gugenheim J, Ouzan D, Katkhouda N, Mouiel J. Orthotopic liver transplantation with and without peritoneal drainage: a comparative study. Transplant Proc. 1999 Feb-Mar;31(1-2):556-7. doi: 10.1016/s0041-1345(98)01553-x. No abstract available.
citation: Hampe T, Dogan A, Encke J, Mehrabi A, Schemmer P, Schmidt J, Stiehl A, Sauer P. Biliary complications after liver transplantation. Clin Transplant. 2006;20 Suppl 17:93-6. doi: 10.1111/j.1399-0012.2006.00607.x.
citation: Thethy S, Thomson BNj, Pleass H, Wigmore SJ, Madhavan K, Akyol M, Forsythe JL, James Garden O. Management of biliary tract complications after orthotopic liver transplantation. Clin Transplant. 2004 Dec;18(6):647-53. doi: 10.1111/j.1399-0012.2004.00254.x.