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Trial record 34 of 41 for:    Recruiting, Not yet recruiting, Available Studies | "Gastroparesis"

Proximal Roux-en-y Gastrojejunal Anastomosis on Delayed Gastric Emptying After Pylorus-resecting Pancreaticoduodenectomy

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ClinicalTrials.gov Identifier: NCT02954302
Recruitment Status : Recruiting
First Posted : November 3, 2016
Last Update Posted : November 3, 2016
Sponsor:
Collaborators:
LanZhou University
Eastern Hepatobiliary Surgery Hospital
Information provided by (Responsible Party):
The First Affiliated Hospital of Xiamen University

Brief Summary:
This study aims to evaluate whether the incidence of delayed gastric emptying (DGE) can be reduced by proximal Roux-en-y gastrojejunal anastomosis in comparison with the standard gastrojejunal anastomosis in pylorus-resecting pancreaticoduodenectomy (PrPD).

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Bile Duct Cancer Duodenal Cancer Procedure: PrPD with proximal Roux-en-y gastrojejunal anastomosis Procedure: conventional PrPD Not Applicable

Detailed Description:
Delayed gastric emptying (DGE) is a common complication after pancreaticoduodenectomy (PD), occurring in 20% to 70% of the patients. DGE is usually not a life-threatening complication, but it contributes significantly to increased length of hospital stay, health care costs, and patient discomfort. In a recent study by Sakamoto et al, proximal Roux-en-y gastrojejunal anastomosis is associated with a reduced incidence of DGE after pylorus-resecting pancreaticoduodenectomy (PrPD); however, these results may have been biased because of the retrospective nature. Therefore, the investigators conducted the present randomized controlled trial (RCT) to evaluate the impact of the proximal Roux-en-y gastrojejunal anastomosis on reducing DGE following PrPD.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Proximal Roux-en-y Gastrojejunal Anastomosis on Delayed Gastric Emptying After Pylorus-resecting Pancreaticoduodenectomy: A Randomized Controlled Trial
Study Start Date : September 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PrPD with RGA
Patients who will undergo PrPD with proximal Roux-en-y gastrojejunal anastomosis.
Procedure: PrPD with proximal Roux-en-y gastrojejunal anastomosis
the distal antrum was divided about 1 to 2 cm proximal to the pylorus ring, preserving more than 95% of the stomach. The proximal jejunum was divided approximately 2 to 4 cm distal to the duodeno-jejunal junction. After completion of the resection, the proximal end of the first loop of jejunum was then brought through the transverse mesocolon, and the gastrojejunal anastomosis (GJA) was performed in two layers by using 3-0 PDS sutures and 4-0 silk sutures in an end-to-side fashion. The jejunum was then divided 35 to 40 cm distal to the GJA, and the distal limb was brought separately through the transverse mesocolon to be placed in the duodenal bed for reconstruction of the pancreatojejunal anastomosis (PJA) and hepatojejunal anastomosis (HJA).

Experimental: conventional PrPD
Patients who will undergo conventional PrPD.
Procedure: conventional PrPD
After completion of the pancreatojejunal anastomosis (PJA) and hepatojejunal anastomosis (HJA), a hand-sewn, isoperistaltic GJA was performed 25 to 30 cm distal to the HJA in two layers by using 3-0 polydioxanone (PDS) sutures and 4-0 silk sutures.




Primary Outcome Measures :
  1. Delayed gastric emptying,rate [ Time Frame: 60 days after operation ]

    The severity of DGE was classified into 3 grades (A, B, or C) according to the ISGPS's clinical criteria, based on the patient's clinical course and postoperative management, such as the need for NGT in the postoperative period or the inability to tolerate solid oral intake.

    Grade A was defined as needing the NGT for more than 7 days or reinsertion of the NGT after postoperative day 3, or as being unable to tolerate a solid diet by postoperative day 7.

    Grade B was defined as needing for NGT for 8 to 14 days after surgery or reinsertion of the NGT after day 7, or as being unable to tolerate a solid diet by postoperative day 14.

    Grade C was defined as needing the NGT for more than 14 days or reinsertion of the NGT after day 14, or as being unable to tolerate a solid diet by day 21.



Secondary Outcome Measures :
  1. Morbidity,rate [ Time Frame: 60 days after operation ]
  2. Mortality,rate [ Time Frame: 60 days after operation ]
  3. Length of hospital stay,days [ Time Frame: 60 days after operation ]
  4. Pancreatic fistula,rate [ Time Frame: 60 days after operation ]
  5. Hemorrhage,rate [ Time Frame: 60 days after operation ]
  6. Bile leakage,rate [ Time Frame: 60 days after operation ]
  7. Intra-abdominal abscess,rate [ Time Frame: 60 days after operation ]
  8. wound infection,rate [ Time Frame: 60 days after operation ]

Other Outcome Measures:
  1. nonsurgical complications,rate [ Time Frame: 60 days after operation ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who were scheduled to undergo PD and provided written informed consent.
  • In the opinion of the surgeon, the subject has no medical contraindications to PD.
  • At least 18 years of age.

Exclusion Criteria:

  • Patients who underwent other surgical procedures than PD, such as total pancreatectomy (TP) or a palliative biliary and gastroenteric anastomosis.
  • Drug abusers or alcoholics.
  • Patient who have previous transabdominal surgery.
  • The patient who were scheduled to undergo laparoscopic PD.
  • The patient who does not want to participate the clinical trials.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02954302


Contacts
Contact: Mingqiang Lin, Dr 8605922139708 80218353@qq.com
Contact: Yanming Zhou, Dr 8605922139708 zhouymsxy@sina.cn

Locations
China, Fujian
First affiliated Hospital of Xiamen University Recruiting
Xiamen, Fujian, China, 361003
Contact: Minqiang Lin, Dr    8605922139708 ext 8605922139908    80218353@qq.com   
Principal Investigator: Yanming Zhou, Dr         
Sub-Investigator: Xiaofeng Zhang, Dr         
Sub-Investigator: Feng Yu, Dr         
Sub-Investigator: Lupeng Wu, Dr         
Sub-Investigator: AIling Song, Dr         
Sponsors and Collaborators
The First Affiliated Hospital of Xiamen University
LanZhou University
Eastern Hepatobiliary Surgery Hospital
Investigators
Principal Investigator: Yanming Zhou, Dr First affiliated Hospital of Xiamen University

Publications of Results:
Responsible Party: The First Affiliated Hospital of Xiamen University
ClinicalTrials.gov Identifier: NCT02954302     History of Changes
Other Study ID Numbers: FAHXMU-2016-04
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data.

Keywords provided by The First Affiliated Hospital of Xiamen University:
Delayed gastric emptying
pancreaticoduodenectomy

Additional relevant MeSH terms:
Gastroparesis
Pancreatic Neoplasms
Bile Duct Neoplasms
Cholangiocarcinoma
Duodenal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Biliary Tract Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Stomach Diseases
Gastrointestinal Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Duodenal Diseases
Intestinal Diseases