A Prospective Randomized Controlled Multicenter Trial of Delayed Gastric Emptying (DGE) After Pancreaticoduodenectomy Evaluating by Gastrointestinal Reconstruction
|ClinicalTrials.gov Identifier: NCT01460550|
Recruitment Status : Unknown
Verified March 2015 by Ippei Matsumoto, Kobe University.
Recruitment status was: Recruiting
First Posted : October 27, 2011
Last Update Posted : April 1, 2015
|Condition or disease||Intervention/treatment||Phase|
|Postprocedural Delayed Gastric Emptying||Procedure: Retrocolic gastro- or duodeno- jejunostomy in hte pancreaticoduodenectomy Procedure: Antecolic gastro- or duodeno- jejunostomy in the pancreaticoduodenectomy||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison Between Antecolic and Retrocolic Gastrointestinal Reconstruction in Delayed Gastric Emptying After Pancreaticoduodenectomy: A Prospective Randomized Controlled Multicenter Trial|
|Study Start Date :||November 2011|
|Estimated Primary Completion Date :||October 2016|
|Estimated Study Completion Date :||March 2017|
|Experimental: gastrointestinal reconstruction||
Procedure: Retrocolic gastro- or duodeno- jejunostomy in hte pancreaticoduodenectomy
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.
Procedure: Antecolic gastro- or duodeno- jejunostomy in the pancreaticoduodenectomy
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.
- Incident rate of delayed gastric emptying [ Time Frame: during hospital stay after surgery, an expected average of 3 weeks ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460550
|Contact: Ippei Matsumoto, MDemail@example.com|
|Kobe, Hyogo, Japan, 6500017|
|Contact: Ippei Matsumoto, MD +81-78382-6302 firstname.lastname@example.org|
|Study Chair:||Yonson Ku, MD||Kobe University|