Clinical trial NCT04227951: Gastrectomy With or Without Drainage (ADiGe)?
Official title: A Randomised Multicentre Controlled Trial of Gastrectomy With or Without Prophylactic Abdominal Drainage. The Abdominal Drain in Gastrectomy Trial (ADiGe Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Keywords: Gastrectomy
Drain
Drainage
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2020-01-14
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prophylactic use of anastomotic drain in upper gastrointestinal surgery has been questioned in the last 15 years but only small studies have been conducted. In 2015 a Cochrane meta analysis on four Randomized Controlled Trials (RCT) concluded that there was no convincing evidence to the routine drain placement in gastrectomy. Nevertheless the Authors evidenced the moderate/low methodological quality of the included studies and highlighted how 3 out of four came from Eastern countries. Despite the above mentioned limits, Enhanced Recovery After Surgery (ERAS) society published the guidelines for gastrectomy that strongly recommend, with high evidence level, to avoid routine use of drain in gastric surgery. After 2015 some other retrospective studies have been published, all with inconsistent results. Our objective is to perform a multicentre prospective trial in a large western cohort of patients to establish wether avoid routine use of anastomotic drain does not led to an increasing of postoperative invasive procedure.


Eligibility criteria: Inclusion Criteria:

* all consecutive patients that undergo total or subtotal gastrectomy with a curative intent, for histologically proven gastric cancer or esophago-gastric junction cancer Siewert type II or III, in surgical investigator centres from the beginning of the study until reaching the accrual number
* esophageal involvement \<= 2 cm
* patients undergoing upfront surgery or treated with a neoadjuvant/perioperative chemotherapy
* open, hybrid, laparoscopic or robotic approach
* all types of anastomosis (circular stapled, linear stapled, hand sewn)

Exclusion Criteria:

* refuse to sign informed consent
* age \<18
* Heart failure New York Heart Association (NYHA) class IV
* severe liver disease (Child \>= 7)
* pregnancy
* metastatic disease
* emergency surgery
* palliative surgery
* operation different from total or subtotal oncological gastrectomies (e.g. pylorus preserving, proximal gastrectomy)
* lymphnodal dissection \<D1
* reconstruction different from Roux-en-Y or Billroth II
* multiple organ resections (except for cholecystectomy)
* gastric cancer with duodenal involvement
* intraoperative Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Primary outcomes:
measure: 30 day reoperation AND/OR additional drain placement
timeFrame: 30 days after the operation
Secondary outcomes:
measure: Overall mortality
timeFrame: 90 days after the operation
measure: Overall morbidity
timeFrame: 30 days after the operation OR in hospital if hospitalization is longer than 30 days, up to 90 days of hospitalization
measure: Length of hospital stay
timeFrame: From the day of operation until discharge (home or other facilities) or death for any cause whichever came first, assessed up to 100 months.
measure: Drain related complications
timeFrame: From the day of operation until drain removal up to 90 days after the operation
Other outcomes:
Locations:
city: Forlì
country: Italy
facility: Ospedale Morgagni di Forlì - Chirurgia generale
state: Forlì-Cesena
city: Orbassano
country: Italy
facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga- Chirurgia Generale
state: Torino
city: Bergamo
country: Italy
facility: Policlinico San Marco, GSD - Chirurgia Generale ed Oncologica
city: Bologna
country: Italy
facility: Policlinico S.Orsola-Malpighi - Dipartimento di Chirurgia Generale
city: Cremona
country: Italy
facility: Ospedale di Cremona
city: Milano
country: Italy
facility: ASST Grande Ospedale metropolitano Niguarda - Chirurgia generale oncologica e mini-invasiva
city: Milan
country: Italy
facility: Ospedale San Raffaele - Chirurgia Gastroenterologica -
city: Modena
country: Italy
facility: Azienda Ospedaliero Universitaria Modena - Chirurgia Oncologica, Generale e d'Urgenza
city: Napoli
country: Italy
facility: Ospedale Federico II di Napoli- Chirurgia Generale
city: Parma
country: Italy
facility: Azienda Ospedaliera Universitaria Parma - UO Clinica Chirurgica Generale
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Borgo Trento - Chirurgia Generale ed Esofago Stomaco
Study officials:
affiliation: Università degli studi di Verona
name: Giovanni de Manzoni, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang Z, Chen J, Su K, Dong Z. Abdominal drainage versus no drainage post-gastrectomy for gastric cancer. Cochrane Database Syst Rev. 2015 May 11;2015(5):CD008788. doi: 10.1002/14651858.CD008788.pub3.
citation: Mortensen K, Nilsson M, Slim K, Schafer M, Mariette C, Braga M, Carli F, Demartines N, Griffin SM, Lassen K; Enhanced Recovery After Surgery (ERAS(R)) Group. Consensus guidelines for enhanced recovery after gastrectomy: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Br J Surg. 2014 Sep;101(10):1209-29. doi: 10.1002/bjs.9582. Epub 2014 Jul 21.
citation: Schots JPM, Luyer MDP, Nieuwenhuijzen GAP. Abdominal Drainage and Amylase Measurement for Detection of Leakage After Gastrectomy for Gastric Cancer. J Gastrointest Surg. 2018 Jul;22(7):1163-1170. doi: 10.1007/s11605-018-3789-7. Epub 2018 May 7.
citation: Dann GC, Squires MH 3rd, Postlewait LM, Kooby DA, Poultsides GA, Weber SM, Bloomston M, Fields RC, Pawlik TM, Votanopoulos KI, Schmidt CR, Ejaz A, Acher AW, Worhunsky DJ, Saunders N, Swords DS, Jin LX, Cho CS, Winslow ER, Russell MC, Staley CA, Maithel SK, Cardona K. Value of Peritoneal Drain Placement After Total Gastrectomy for Gastric Adenocarcinoma: A Multi-institutional Analysis from the US Gastric Cancer Collaborative. Ann Surg Oncol. 2015 Dec;22 Suppl 3:S888-97. doi: 10.1245/s10434-015-4636-7. Epub 2015 May 29.
citation: Hirahara N, Matsubara T, Hayashi H, Takai K, Fujii Y, Tajima Y. Significance of prophylactic intra-abdominal drain placement after laparoscopic distal gastrectomy for gastric cancer. World J Surg Oncol. 2015 May 12;13:181. doi: 10.1186/s12957-015-0591-9.
citation: Lee J, Choi YY, An JY, Seo SH, Kim DW, Seo YB, Nakagawa M, Li S, Cheong JH, Hyung WJ, Noh SH. Do All Patients Require Prophylactic Drainage After Gastrectomy for Gastric Cancer? The Experience of a High-Volume Center. Ann Surg Oncol. 2015 Nov;22(12):3929-37. doi: 10.1245/s10434-015-4521-4. Epub 2015 Apr 7.
citation: Weindelmayer J, Mengardo V, Veltri A, Baiocchi GL, Giacopuzzi S, Verlato G, de Manzoni G; Italian Research Group for Gastric Cancer (GIRCG). Utility of Abdominal Drain in Gastrectomy (ADiGe) Trial: study protocol for a multicenter non-inferiority randomized trial. Trials. 2021 Feb 17;22(1):152. doi: 10.1186/s13063-021-05102-1.