Gastrectomy With or Without Drainage (ADiGe)?

NCT ID: NCT04227951

Last Updated: 2023-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 404 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-17
• Study Completion Date: 2023-03-29

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.

Conditions

Gastric Cancer

Keywords

Gastrectomy; Drain; Drainage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Drain

Participants enrolled in this arm have an abdominal drain positioned at the end of the operation (any type, inserted from right flank with the tip close to the esophago-jejunal or Gastro-jejunal anastomosis and the duodenal stump). Drain will stay in place until postoperative day (POD) 4th (drain output and quality will be registered). If normal drain debt and patient have no abdominal complications that need reoperation and/or percutaneous drain placement until POD 4, a methylene-blue test is be performed (200 ml water + 5 ml blue orally, check drain after 60 minutes: negative test if no blu was seen in the drain). If negative-blue test drain can be removed according to centre preference (no strict POD defined); if positive-blue test complication will be treated according to centre preference. Only in this arm drain related complications are registered. Need for reoperation and/or percutaneous drain placement (primary outcome) are registered.

Group Type: SHAM_COMPARATOR

Drain placement

Intervention Type: DEVICE

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.

No Drain

Participants enrolled in this arm do not have any abdominal drain placed at the end of the operation. Postoperative management (e.g. resume of oral intake, anastomosis integrity tests) is left to centre preference. Need for reoperation and/or percutaneous drain placement (primary outcome) are registered.

Group Type: EXPERIMENTAL

Avoid drain placement

Intervention Type: DEVICE

In No Drain arm (experimental) no abdominal drain is placed at the end of the operation.

Interventions

Avoid drain placement

In No Drain arm (experimental) no abdominal drain is placed at the end of the operation.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera Universitaria Integrata Verona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giovanni de Manzoni, Prof

Role: PRINCIPAL_INVESTIGATOR

Università degli studi di Verona

Locations

Ospedale Morgagni di Forlì - Chirurgia generale

Forlì, Forlì-Cesena, Italy

Azienda Ospedaliero-Universitaria San Luigi Gonzaga- Chirurgia Generale

Orbassano, Torino, 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 San Raffaele - Chirurgia Gastroenterologica -

Milan, , Italy

ASST Grande Ospedale metropolitano Niguarda - Chirurgia generale oncologica e mini-invasiva

Milan, , Italy

Azienda Ospedaliero Universitaria Modena - Chirurgia Oncologica, Generale e d'Urgenza

Modena, , Italy

Ospedale Federico II di Napoli- Chirurgia Generale

Napoli, , Italy

Azienda Ospedaliera Universitaria Parma - UO Clinica Chirurgica Generale

Parma, , Italy

Azienda Ospedaliera Universitaria Integrata Borgo Trento - Chirurgia Generale ed Esofago Stomaco

Verona, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 25961741 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25047143 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29736661 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26023037 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25962503 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25845430 (View on PubMed)

Weindelmayer J, Mengardo V, Ascari F, Baiocchi GL, Casadei R, De Palma GD, De Pascale S, Elmore U, Ferrari GC, Framarini M, Gelmini R, Gualtierotti M, Marchesi F, Milone M, Puca L, Reddavid R, Rosati R, Solaini L, Torroni L, Totaro L, Veltri A, Verlato G, de Manzoni G; Italian Research Group for Gastric Cancer (GIRCG). Prophylactic Drain Placement and Postoperative Invasive Procedures After Gastrectomy: The Abdominal Drain After Gastrectomy (ADIGE) Randomized Clinical Trial. JAMA Surg. 2025 Feb 1;160(2):135-143. doi: 10.1001/jamasurg.2024.5227.

Reference Type: DERIVED

PMID: 39602143 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33596959 (View on PubMed)

Other Identifiers

2245CESC

Identifier Type: -

Identifier Source: org_study_id