search
Back to results

A Prospective Randomized Controlled Multicenter Trial of Delayed Gastric Emptying (DGE) After Pancreaticoduodenectomy Evaluating by Gastrointestinal Reconstruction

Primary Purpose

Postprocedural Delayed Gastric Emptying

Status
Unknown status
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Retrocolic gastro- or duodeno- jejunostomy in hte pancreaticoduodenectomy
Antecolic gastro- or duodeno- jejunostomy in the pancreaticoduodenectomy
Sponsored by
Kobe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postprocedural Delayed Gastric Emptying focused on measuring delayed gastric emptying(DGE), pancreaticoduodenectomy(PD), randomized controlled trial(RCT), gastro- or duodeno- jejunostomy reconstruction, morbidity

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with pancreatic-biliary disease who undergo pancreaticoduodenectomy

Exclusion Criteria:

  • patients who have the history of gastrectomy
  • patients who have severe cardiorespiratory dysfunction
  • patients who have liver cirrhosis or are receiving dialysis
  • patients who were diagnosed inadequacy for this study by a physician

Sites / Locations

  • Kobe UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

gastrointestinal reconstruction

Arm Description

Outcomes

Primary Outcome Measures

Incident rate of delayed gastric emptying
DGE represents the inability to return to a standard diet by the end of the first postoperative week and includes prolonged nasogastric intubation of the patient. Three different grades (A,B,and C) were defined based on the impact on the clinical course and on postoperative management by ISGPS.

Secondary Outcome Measures

Full Information

First Posted
October 11, 2011
Last Updated
March 31, 2015
Sponsor
Kobe University
search

1. Study Identification

Unique Protocol Identification Number
NCT01460550
Brief Title
A Prospective Randomized Controlled Multicenter Trial of Delayed Gastric Emptying (DGE) After Pancreaticoduodenectomy Evaluating by Gastrointestinal Reconstruction
Official Title
Comparison Between Antecolic and Retrocolic Gastrointestinal Reconstruction in Delayed Gastric Emptying After Pancreaticoduodenectomy: A Prospective Randomized Controlled Multicenter Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kobe University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the incidence of delayed gastric emptying in patient with pancreaticoduodenectomy between antecolic and retrocolic gastrointestinal reconstruction.
Detailed Description
The purpose of this study is to evaluate the incidence of delayed gastric emptying in patient with pancreaticoduodenectomy between antecolic and retrocolic gastrointestinal reconstruction. Delayed gastric emptying after pancreaticoduodenectomy is important to affect the postoperative course and QOL. We conducted a prospective randomized trial on 240 patients who underwent pancreaticoduodenectomy for comparing between antecolic and retrocolic gastrointestinal reconstruction. The primary endpoint was defined as incidence of delayed gastric emptying by ISGPS criteria. The secondary endpoint was defined as incidence of other postoperative morbidity. Patients were recruited into this study before surgery, on the basis of whether pancreatic head resection was anticipated for pancreatic head and periampullary disease, and an appropriate informed consent was obtained. Exclusion criteria was 1) patients who have the history of gastrectomy, 2) patients who have severe cardiorespiratory dysfunction, 3) patients who have liver cirrhosis or are receiving dialysis, and 4) patients who were diagnosed inadequate for this study by a physician.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postprocedural Delayed Gastric Emptying
Keywords
delayed gastric emptying(DGE), pancreaticoduodenectomy(PD), randomized controlled trial(RCT), gastro- or duodeno- jejunostomy reconstruction, morbidity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
gastrointestinal reconstruction
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Retrocolic gastro- or duodeno- jejunostomy in hte pancreaticoduodenectomy
Intervention Description
The duodenojejunostomy or gastrojejunostomy was constructed in two layers or single layer. For the retrocolic reconstruction, the jejunal loop was anastomosed to the duodenum or stomach through a separate mesocolic window on the left of the middle colic vessels.
Intervention Type
Procedure
Intervention Name(s)
Antecolic gastro- or duodeno- jejunostomy in the pancreaticoduodenectomy
Intervention Description
The duodenojejunostomy or gastrojejunostomy was constructed in two layers or single layer. For the antecolic reconstruction, the jejunal loop about 30 cm distal to the hepaticojejunostomy, was brought up anterior to the transverse colon and anastomosed to the duodenum or stomach.
Primary Outcome Measure Information:
Title
Incident rate of delayed gastric emptying
Description
DGE represents the inability to return to a standard diet by the end of the first postoperative week and includes prolonged nasogastric intubation of the patient. Three different grades (A,B,and C) were defined based on the impact on the clinical course and on postoperative management by ISGPS.
Time Frame
during hospital stay after surgery, an expected average of 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with pancreatic-biliary disease who undergo pancreaticoduodenectomy Exclusion Criteria: patients who have the history of gastrectomy patients who have severe cardiorespiratory dysfunction patients who have liver cirrhosis or are receiving dialysis patients who were diagnosed inadequacy for this study by a physician
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ippei Matsumoto, MD
Phone
+81-78-382-6302
Email
imatsu@med.kobe-u.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yonson Ku, MD
Organizational Affiliation
Kobe University
Official's Role
Study Chair
Facility Information:
Facility Name
Kobe University
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
6500017
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ippei Matsumoto, MD
Phone
+81-78382-6302
Email
imatsu@med.kobe-u.ac.jp

12. IPD Sharing Statement

Citations:
PubMed Identifier
17122618
Citation
DeOliveira ML, Winter JM, Schafer M, Cunningham SC, Cameron JL, Yeo CJ, Clavien PA. Assessment of complications after pancreatic surgery: A novel grading system applied to 633 patients undergoing pancreaticoduodenectomy. Ann Surg. 2006 Dec;244(6):931-7; discussion 937-9. doi: 10.1097/01.sla.0000246856.03918.9a.
Results Reference
background
PubMed Identifier
17981197
Citation
Wente MN, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Traverso LW, Yeo CJ, Buchler MW. Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the International Study Group of Pancreatic Surgery (ISGPS). Surgery. 2007 Nov;142(5):761-8. doi: 10.1016/j.surg.2007.05.005.
Results Reference
background
PubMed Identifier
19474680
Citation
Akizuki E, Kimura Y, Nobuoka T, Imamura M, Nagayama M, Sonoda T, Hirata K. Reconsideration of postoperative oral intake tolerance after pancreaticoduodenectomy: prospective consecutive analysis of delayed gastric emptying according to the ISGPS definition and the amount of dietary intake. Ann Surg. 2009 Jun;249(6):986-94. doi: 10.1097/SLA.0b013e3181a63c4c.
Results Reference
background
PubMed Identifier
20632270
Citation
Welsch T, Borm M, Degrate L, Hinz U, Buchler MW, Wente MN. Evaluation of the International Study Group of Pancreatic Surgery definition of delayed gastric emptying after pancreatoduodenectomy in a high-volume centre. Br J Surg. 2010 Jul;97(7):1043-50. doi: 10.1002/bjs.7071.
Results Reference
background
PubMed Identifier
17262740
Citation
Hayashibe A, Kameyama M, Shinbo M, Makimoto S. The surgical procedure and clinical results of subtotal stomach preserving pancreaticoduodenectomy (SSPPD) in comparison with pylorus preserving pancreaticoduodenectomy (PPPD). J Surg Oncol. 2007 Feb 1;95(2):106-9. doi: 10.1002/jso.20608.
Results Reference
background
PubMed Identifier
20018335
Citation
Hashimoto Y, Traverso LW. Incidence of pancreatic anastomotic failure and delayed gastric emptying after pancreatoduodenectomy in 507 consecutive patients: use of a web-based calculator to improve homogeneity of definition. Surgery. 2010 Apr;147(4):503-15. doi: 10.1016/j.surg.2009.10.034. Epub 2009 Dec 16.
Results Reference
background
PubMed Identifier
19744455
Citation
Park JS, Hwang HK, Kim JK, Cho SI, Yoon DS, Lee WJ, Chi HS. Clinical validation and risk factors for delayed gastric emptying based on the International Study Group of Pancreatic Surgery (ISGPS) Classification. Surgery. 2009 Nov;146(5):882-7. doi: 10.1016/j.surg.2009.05.012. Epub 2009 Jul 18.
Results Reference
background
PubMed Identifier
15492552
Citation
Tran KT, Smeenk HG, van Eijck CH, Kazemier G, Hop WC, Greve JW, Terpstra OT, Zijlstra JA, Klinkert P, Jeekel H. Pylorus preserving pancreaticoduodenectomy versus standard Whipple procedure: a prospective, randomized, multicenter analysis of 170 patients with pancreatic and periampullary tumors. Ann Surg. 2004 Nov;240(5):738-45. doi: 10.1097/01.sla.0000143248.71964.29.
Results Reference
background
PubMed Identifier
18427904
Citation
Akizuki E, Kimura Y, Nobuoka T, Imamura M, Nishidate T, Mizuguchi T, Furuhata T, Hirata K. Prospective nonrandomized comparison between pylorus-preserving and subtotal stomach-preserving pancreaticoduodenectomy from the perspectives of DGE occurrence and postoperative digestive functions. J Gastrointest Surg. 2008 Jul;12(7):1185-92. doi: 10.1007/s11605-008-0513-z. Epub 2008 Apr 22.
Results Reference
background
PubMed Identifier
11807364
Citation
Murakami H, Suzuki H, Nakamura T. Pancreatic fibrosis correlates with delayed gastric emptying after pylorus-preserving pancreaticoduodenectomy with pancreaticogastrostomy. Ann Surg. 2002 Feb;235(2):240-5. doi: 10.1097/00000658-200202000-00012.
Results Reference
background
PubMed Identifier
13129553
Citation
Riediger H, Makowiec F, Schareck WD, Hopt UT, Adam U. Delayed gastric emptying after pylorus-preserving pancreatoduodenectomy is strongly related to other postoperative complications. J Gastrointest Surg. 2003 Sep-Oct;7(6):758-65. doi: 10.1016/s1091-255x(03)00109-4.
Results Reference
background
PubMed Identifier
14707733
Citation
Horstmann O, Markus PM, Ghadimi MB, Becker H. Pylorus preservation has no impact on delayed gastric emptying after pancreatic head resection. Pancreas. 2004 Jan;28(1):69-74. doi: 10.1097/00006676-200401000-00011.
Results Reference
background
PubMed Identifier
12192322
Citation
Yeo CJ, Cameron JL, Lillemoe KD, Sohn TA, Campbell KA, Sauter PK, Coleman J, Abrams RA, Hruban RH. Pancreaticoduodenectomy with or without distal gastrectomy and extended retroperitoneal lymphadenectomy for periampullary adenocarcinoma, part 2: randomized controlled trial evaluating survival, morbidity, and mortality. Ann Surg. 2002 Sep;236(3):355-66; discussion 366-8. doi: 10.1097/00000658-200209000-00012.
Results Reference
background
PubMed Identifier
12788421
Citation
Park YC, Kim SW, Jang JY, Ahn YJ, Park YH. Factors influencing delayed gastric emptying after pylorus-preserving pancreatoduodenectomy. J Am Coll Surg. 2003 Jun;196(6):859-65. doi: 10.1016/S1072-7515(03)00127-3.
Results Reference
background
PubMed Identifier
19083149
Citation
Chijiiwa K, Imamura N, Ohuchida J, Hiyoshi M, Nagano M, Otani K, Kai M, Kondo K. Prospective randomized controlled study of gastric emptying assessed by (13)C-acetate breath test after pylorus-preserving pancreaticoduodenectomy: comparison between antecolic and vertical retrocolic duodenojejunostomy. J Hepatobiliary Pancreat Surg. 2009;16(1):49-55. doi: 10.1007/s00534-008-0004-3. Epub 2008 Dec 16.
Results Reference
background
PubMed Identifier
16301447
Citation
Hartel M, Wente MN, Hinz U, Kleeff J, Wagner M, Muller MW, Friess H, Buchler MW. Effect of antecolic reconstruction on delayed gastric emptying after the pylorus-preserving Whipple procedure. Arch Surg. 2005 Nov;140(11):1094-9. doi: 10.1001/archsurg.140.11.1094.
Results Reference
background
PubMed Identifier
19548039
Citation
Nikfarjam M, Kimchi ET, Gusani NJ, Shah SM, Sehmbey M, Shereef S, Staveley-O'Carroll KF. A reduction in delayed gastric emptying by classic pancreaticoduodenectomy with an antecolic gastrojejunal anastomosis and a retrogastric omental patch. J Gastrointest Surg. 2009 Sep;13(9):1674-82. doi: 10.1007/s11605-009-0944-1. Epub 2009 Jun 23.
Results Reference
background
PubMed Identifier
16495694
Citation
Tani M, Terasawa H, Kawai M, Ina S, Hirono S, Uchiyama K, Yamaue H. Improvement of delayed gastric emptying in pylorus-preserving pancreaticoduodenectomy: results of a prospective, randomized, controlled trial. Ann Surg. 2006 Mar;243(3):316-20. doi: 10.1097/01.sla.0000201479.84934.ca.
Results Reference
background
PubMed Identifier
32773628
Citation
Toyama H, Matsumoto I, Mizumoto T, Fujita H, Tsuchida S, Kanbara Y, Kadowaki Y, Maeda H, Okano K, Fukuoka M, Takase S, Shirakawa S, Terai S, Mukubo H, Ishida J, Yamashita H, Ueno K, Tanaka M, Kido M, Ajiki T, Murakami S, Nishimura K, Fukumoto T. Influence of the Retrocolic Versus Antecolic Route for Alimentary Tract Reconstruction on Delayed Gastric Emptying After Pancreatoduodenectomy: A Multicenter, Noninferiority Randomized Controlled Trial. Ann Surg. 2021 Dec 1;274(6):935-944. doi: 10.1097/SLA.0000000000004072.
Results Reference
derived
Links:
URL
http://www.med.kobe-u.ac.jp/hbps/index.html
Description
Click here for more information about this study: Clinical Trial of DGE after PD

Learn more about this trial

A Prospective Randomized Controlled Multicenter Trial of Delayed Gastric Emptying (DGE) After Pancreaticoduodenectomy Evaluating by Gastrointestinal Reconstruction

We'll reach out to this number within 24 hrs