Back to results

Gastrectomy With or Without Drainage (ADiGe)? (ADiGe)

Primary Purpose

Gastric Cancer

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Avoid drain placement

Drain placement

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastrectomy, Drain, Drainage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Ospedale Morgagni di Forlì - Chirurgia generale
Azienda Ospedaliero-Universitaria San Luigi Gonzaga- Chirurgia Generale
Policlinico San Marco, GSD - Chirurgia Generale ed Oncologica
Policlinico S.Orsola-Malpighi - Dipartimento di Chirurgia Generale
ASST Grande Ospedale metropolitano Niguarda - Chirurgia generale oncologica e mini-invasiva
Ospedale San Raffaele - Chirurgia Gastroenterologica -
Azienda Ospedaliero Universitaria Modena - Chirurgia Oncologica, Generale e d'Urgenza
Ospedale Federico II di Napoli- Chirurgia Generale
Azienda Ospedaliera Universitaria Parma - UO Clinica Chirurgica Generale
Azienda Ospedaliera Universitaria Integrata Borgo Trento - Chirurgia Generale ed Esofago Stomaco

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Drain

No Drain

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Overall mortality

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.

Length of hospital stay

Drain related complications

Only in Drain Group complications related to drain placement (e.g. bleeding from drain site) will be recorded

Full Information

NCT ID

NCT04227951

First Posted

January 8, 2020

Last Updated

July 19, 2023

Sponsor

Azienda Ospedaliera Universitaria Integrata Verona

1. Study Identification

Unique Protocol Identification Number

NCT04227951

Brief Title

Gastrectomy With or Without Drainage (ADiGe)?

Acronym

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

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

December 17, 2019 (Actual)

Primary Completion Date

January 28, 2023 (Actual)

Study Completion Date

March 29, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Azienda Ospedaliera Universitaria Integrata Verona

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

Keywords

Gastrectomy, Drain, Drainage

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Masking Description

The leading surgeon and the patient will be blinded to the arm assigned until the end of the operation. No blinding is provided for the patient, care providers, or coordinating researcher after the operation. After the operation we thought that was unreliable to go ahead with participants blindness considering that one arm has an evident drain and the other arm has no drain. Considering that clinicians will need to check drain quality and remove the tube in treatment group we considered not possible to mask the care providers or investigators on this practice.

Allocation

Randomized

Enrollment

404 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Drain

Arm Type

Sham Comparator

Arm Description

Arm Title

No Drain

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Avoid drain placement

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Drain placement

Intervention Description

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.

Primary Outcome Measure Information:

Title

30 day reoperation AND/OR additional drain placement

Description

Incidence of reoperation AND/OR percutaneous placement of an additional drain within postoperative day 30 (composite outcome)

Time Frame

30 days after the operation

Secondary Outcome Measure Information:

Title

Overall mortality

Time Frame

90 days after the operation

Title

Overall morbidity

Description

Time Frame

30 days after the operation OR in hospital if hospitalization is longer than 30 days, up to 90 days of hospitalization

Title

Length of hospital stay

Time Frame

From the day of operation until discharge (home or other facilities) or death for any cause whichever came first, assessed up to 100 months.

Title

Drain related complications

Description

Only in Drain Group complications related to drain placement (e.g. bleeding from drain site) will be recorded

Time Frame

From the day of operation until drain removal up to 90 days after the operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Giovanni de Manzoni, Prof

Organizational Affiliation

Università degli studi di Verona

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ospedale Morgagni di Forlì - Chirurgia generale

City

Forlì

State/Province

Forlì-Cesena

Country

Italy

Facility Name

Azienda Ospedaliero-Universitaria San Luigi Gonzaga- Chirurgia Generale

City

Orbassano

State/Province

Torino

Country

Italy

Facility Name

Policlinico San Marco, GSD - Chirurgia Generale ed Oncologica

City

Bergamo

Country

Italy

Facility Name

Policlinico S.Orsola-Malpighi - Dipartimento di Chirurgia Generale

City

Bologna

Country

Italy

Facility Name

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

City

Milano

Country

Italy

Facility Name

Ospedale San Raffaele - Chirurgia Gastroenterologica -

City

Milan

Country

Italy

Facility Name

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

City

Modena

Country

Italy

Facility Name

Ospedale Federico II di Napoli- Chirurgia Generale

City

Napoli

Country

Italy

Facility Name

Azienda Ospedaliera Universitaria Parma - UO Clinica Chirurgica Generale

City

Parma

Country

Italy

Facility Name

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

City

Verona

ZIP/Postal Code

37124

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Still evaluating with the study group. Plan is to share all Individual Participant Data that will be collected.

Citations:

PubMed Identifier

25961741

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.

Results Reference

background

PubMed Identifier

25047143

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.

Results Reference

background

PubMed Identifier

29736661

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.

Results Reference

background

PubMed Identifier

26023037

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.

Results Reference

background

PubMed Identifier

25962503

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.

Results Reference

background

PubMed Identifier

25845430

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.

Results Reference

background

PubMed Identifier

33596959

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.

Results Reference

derived

Learn more about this trial

Gastrectomy With or Without Drainage (ADiGe)?

We'll reach out to this number within 24 hrs