Gastrectomy With or Without Drainage (ADiGe)?

Gastric Cancer Clinical Trial

— ADiGe  

Official title:

A Randomised Multicentre Controlled Trial of Gastrectomy With or Without Prophylactic Abdominal Drainage. The Abdominal Drain in Gastrectomy Trial (ADiGe Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04227951
• Other study ID #: 2245CESC
• Status: Completed
• Phase: N/A
• Start date: December 17, 2019
• Est. completion date: March 29, 2023

Study information

• Verified date: November 2023
• Source: Azienda Ospedaliera Universitaria Integrata Verona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 404
• Est. completion date: March 29, 2023
• Est. primary completion date: January 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Device:
• Avoid drain placement
In No Drain arm (experimental) no abdominal drain is placed at the end of the operation.
• Drain placement
In Drain arm (sham comparator) an abdominal drain is inserted in the abdomen from the right flank, passing below the liver (close to the duodenal stump) with the apex behind the esophago-jejunal (in total gastrectomy) or gastro-jejunal (in subtotal gastrectomy) anastomosis.

Locations

Country	Name	City	State
Italy	Policlinico San Marco, GSD - Chirurgia Generale ed Oncologica	Bergamo
Italy	Policlinico S.Orsola-Malpighi - Dipartimento di Chirurgia Generale	Bologna
Italy	Ospedale di Cremona	Cremona
Italy	Ospedale Morgagni di Forlì - Chirurgia generale	Forlì	Forlì-Cesena
Italy	Ospedale San Raffaele - Chirurgia Gastroenterologica -	Milan
Italy	ASST Grande Ospedale metropolitano Niguarda - Chirurgia generale oncologica e mini-invasiva	Milano
Italy	Azienda Ospedaliero Universitaria Modena - Chirurgia Oncologica, Generale e d'Urgenza	Modena
Italy	Ospedale Federico II di Napoli- Chirurgia Generale	Napoli
Italy	Azienda Ospedaliero-Universitaria San Luigi Gonzaga- Chirurgia Generale	Orbassano	Torino
Italy	Azienda Ospedaliera Universitaria Parma - UO Clinica Chirurgica Generale	Parma
Italy	Azienda Ospedaliera Universitaria Integrata Borgo Trento - Chirurgia Generale ed Esofago Stomaco	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Integrata Verona

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30 day reoperation AND/OR additional drain placement	Incidence of reoperation AND/OR percutaneous placement of an additional drain within postoperative day 30 (composite outcome)	30 days after the operation
Secondary	Overall mortality		90 days after the operation
Secondary	Overall morbidity	Complications are classified according to International consensus on a complications list after gastrectomy for cancer - Baiocchi et Al, Gastric Cancer, 2019 and stratified according to Clavien-Dindo classification.	30 days after the operation OR in hospital if hospitalization is longer than 30 days, up to 90 days of hospitalization
Secondary	Length of hospital stay		From the day of operation until discharge (home or other facilities) or death for any cause whichever came first, assessed up to 100 months.
Secondary	Drain related complications	Only in Drain Group complications related to drain placement (e.g. bleeding from drain site) will be recorded	From the day of operation until drain removal up to 90 days after the operation